Lancet device having capillary action

ABSTRACT

A device for sampling body fluid, the device comprising, a main body, a lancet disposed within the main body, a carrier disposed within the main body fixedly attached to the lancet, a biasing means in communication with the lancet and the carrier, an annular space disposed within the main body adjacent the lancet, and a means for measuring a body fluid. Wherein the means for measuring the body fluid may include micro-porous test strips, an electronic testing device, an optical/reflectance testing measuring device, or a visual inspection.

The present application is a continuation of U.S. patent applicationSer. No. 10/054,270, filed on Jan 22, 2002, which is claims the benefitof U.S. Provisional Patent Application No. 60/263,533, filed on Jan. 22,2001, which are hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

This invention relates to lancing devices and methods for obtainingsamples of blood and body fluids for analysis.

BACKGROUND OF THE INVENTION

Many medical procedures in use today require a relatively small sampleof a body fluid, such as blood or interstitial fluid, in the range ofless than 50 μL. It is more cost effective and less traumatic to thepatient to obtain such a sample by lancing or piercing the skin at aselected location, such as the finger or forearm, to enable thecollection of 1 or 2 drops of blood, than by using a phlebotomist todraw a tube of venous blood. With the advent of home use tests for theself monitoring of blood glucose, there is a requirement for a simpleprocedure which can be performed in any setting without a person needingthe assistance of a professional.

Lancets in conventional use generally have a rigid body and a sterileneedle which protrudes from one end. The lancet may be used to piercethe skin, thereby enabling the expression of a blood sample. When acapillary tube or test strip is placed adjacent the expressed blood, thefluid can be collected. By a capillary tube fluid is then transferred toa test device, such as a paper testing strip. Blood is most commonlytaken from the fingertips, where the supply is generally moreaccessible. However, the nerve density in this region causes significantpain in many patients. Sampling of alternative sites, such as earlobesand limbs, is sometimes practiced to lessen the pain. However, thesesites are also less likely to provide sufficient blood samples and canmake blood transfer directly to test devices more difficult.Additionally, it is often difficult for a user to determine whether asufficiently large drop of body fluid has been expressed at the incisionpoint to provide a sufficient sample.

Prior methods of acquiring a blood sample have suffered from the need touse two components and the resulting time lapse between the lancingaction and placement of the capillary tube adjacent the lanced location,potentially allowing contamination or not collecting the fluid expressedfrom the body. One prior method for addressing this concern was tocreate a larger opening and/or to force excess fluid from the body.While this assisted in ensuring an adequate fluid supply, it potentiallycreated a large opening to be healed and could cause the patientadditional pain. Moreover, use of this method requires precise stepswhere the lancet is removed and the capillary tube or test strip is thencorrectly aligned with the lanced location. It is important for correctcollection that no gap or movement of the capillary tube relative to thelanced location occur during collection. There is a need for a system toassist in removal of the lancet and placement of the capillary memberwith a minimum of time and movement. Further, there is a need for acompact, simple system to obtain the desired sample size without theneed for excess lancing of tissue, extra pain to the patient orexpressing an excess volume of body fluid.

To reduce the anxiety of piercing the skin and the associated pain, manyspring loaded devices have been developed. The following two patents arerepresentative of the devices which were developed in the 1980's for usewith home diagnostic test products.

U.S. Pat. No. 4,503,856, Cornell et al., describes a spring loadedlancet injector. The reusable device interfaces with a disposablelancet. The lancet holder may be latched in a retracted position. Whenthe user contacts a release, a spring causes the lancet to pierce theskin at high speed and then retract. The speed is important to reducethe pain associated with the puncture.

Levin et al., U.S. Pat. No. 4,517,978 describes a blood samplinginstrument. This device, which is also spring loaded, uses a standarddisposable lancet. The design enables easy and accurate positioningagainst a fingertip so the impact site can be readily determined. Afterthe lancet pierces the skin, a bounce back spring retracts the lancet toa safe position within the device.

In home settings it is often desirable to collect a sample in order toenable a user to perform a test at home such as glucose monitoring. Someblood glucose monitoring systems, for example, require that the bloodsample be applied to a test device which is in contact with a testinstrument. In such situations, bringing the finger to the test deviceposes some risk of contamination of the sample with a previous samplethat may not have been properly cleaned from the device.

Glucose monitoring devices utilize blood samples in many ways, thoughthe two most common methods are a paper strip and a capillary tube.Monitors that utilize a paper strip require the patient to pierce afinger or appropriate location, withdraw a small sample of blood fromthe piercing, such as by squeezing, and then place the paper strip overthe blood sample and wait until the paper strip absorbs the blood.Monitors that utilize a capillary tube require the patient to follow theprocess described above, except that a paper strip is not utilized tocollect the blood from the skin. Instead, a small capillary tube isplaced over the sample until a sufficient amount of blood is withdrawninto the capillary tube, which is then tested.

In some instances patients are diabetic, that is they are unable toproperly metabolize glucose. In order to regulate insulin levels withintheir bodies, individuals who are diabetic must inject themselves withan appropriate amount of insulin. To determine the proper amount ofinsulin, an individual first must test their blood glucose levels.Typically, a patient has to ‘prick’ a fingertip with a lancet to createan incision through which blood can be withdrawn and placed on a glucosemonitoring strip which then reacts and changes colors indicating theglucose level.

Haynes U.S. Pat. No. 4,920,977 describes a blood collection assemblywith a lancet and micro-collection tube. This device incorporates alancet and collection container in a single device. The lancing andcollection are two separate activities, but the device is a convenientsingle disposable unit for situations when sample collection prior touse is desirable. Similar devices are disclosed in Sarrine U.S. Pat. No.4,360,016 and O'Brian U.S. Pat. No. 4,924,879.

Jordan et al., U.S. Pat. No. 4,850,973 and U.S. Pat. No. 4,858,607disclose a combination device which may alternatively be used as asyringe-type injection device or a lancing device with disposable solidneedle lancet, depending on its configuration.

Lange et al., U.S. Pat. No. 5,318,584 describes a blood lancet devicefor withdrawing blood for diagnostic purposes. This invention uses arotary/sliding transmission system to reduce the pain of lancing. Thepuncture depth is easily and precisely adjustable by the user.

Suzuki et al., U.S. Pat. No. 5,368,047, Dombrowski U.S. Pat. No.4,654,513 and Ishibashi et al., U.S. Pat. No. 5,320,607 each describesuction-type blood samplers. These devices develop suction between thelancing site and the end of the device with the lancet holding mechanismwithdrawing after piercing the skin. A flexible gasket around the end ofthe device helps seal the device end around the puncture site until anadequate sample is withdrawn from the puncture site or the user pullsthe device away.

Garcia et al., U.S. Pat. No. 4,637,403 discloses a combination lancingand blood collection device which uses a capillary action passage toconduct body fluid to a separate test strip in the form of amicro-porous membrane. It is necessary to achieve a precise positioningof the upper end of the capillary passage with respect to the membranein order to ensure that the body fluid from the passage is transferredto the membrane. If an appreciable gap exists therebetween, no transfermay occur. Also, the diameter of the capillary passage is relativelysmall, so the width of a sample transferred to the membrane may be toosmall to be measured by on-site measuring devices such as an opticalmeasuring system or an electrochemical meter.

Single use devices have also been developed for single use tests, i.e.home cholesterol testing, and for institutional use, to eliminate therisk of cross-patient contamination with multi-patient use. Crosman etal., U.S. Pat. No. 4,869,249, and Swierczek U.S. Pat. No. 5,402,798,describe disposable, single use lancing devices.

The disclosures of the above patents are incorporated herein byreference.

An object of the present invention is to provide a disposable lancetunit that may be deployed easily and without causing undue pain.

Another object of the present invention is to provide a one-step systemfor sampling a body fluid for testing.

Another object of the present invention is to provide an apparatus thatwithdraws a blood sample and provides an individual with a blood glucoselevel reading.

A further object of the present invention is to provide an apparatusthat does not require the user to perform multiple steps in order toproduce a blood glucose level reading.

A further object of the present invention is to provide a lancet unithaving capillary functions.

Further objects, features and advantages of the present invention shallbecome apparent from the detailed drawings and descriptions providedherein.

SUMMARY OF THE INVENTION

The present invention provides a device in the preferred embodimentswhich combines a lancing element with a capillary member to integrate ina single unit the lancing of a person's skin and the acquisition of thebody fluid producing by lancing. The invention employs a lancing elementwhich extends within the capillary member, and the body fluid passesthrough the capillary member in the space between the lancing elementand the interior wall of the capillary.

One aspect of the present invention relates to a sampling device forsampling body fluid. The device includes a lancet, a main body and acarrier device for displacing the lancet. The device defines an annularspace disposed about the lancet whereby body fluid is drawn into theannular space through capillary action. In one embodiment, the systemfurther comprises a test strip with a reagent. In one approach, the teststrip is in fluid communication with a distal end of the annular space.In another approach, the test strip is disposed within the annular spacebetween the lancet and the main body. In one preferred embodiment, thetest strip comprises a micro porous membrane.

In another embodiment the sampling device includes a main body, alancet, a carrier for the lancet, and at least one channel disposedwithin the lancet to support a test strip. In this embodiment, the bodyfluid contacts the test strip as the annular space is filled.

In another embodiment, the sampling system includes a main body, alancet, a carrier for the lancet and a testing device. The lancet isdisposed within the main body, thereby creating an annular space betweenthe lancet and the main body, and is advanced and retracted to allow themain body to fill with fluid. The main body is moved to or connected toa testing device for optical or electrochemical testing of the fluid.

In a still further embodiment, the sampling system includes a disposablecartridge mounted to a base unit. The base unit includes actuatingstructure for activating the lancet within the capillary member.Preferably the base unit may be reused and minimizes the materials andstructure in the cartridge.

The present invention also relates to a method of sampling body fluidwhich comprises the steps of positioning the testing device over atesting site, activating the lancet carrying device, whereby the lancetforms a small incision in the testing site through which body fluidflows, drawing the body fluid into the main body of the device tocontact a testing strip or sensors, to provide a user with the results.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a cut-away side view of one apparatus according to apreferred embodiment of the present invention.

FIG. 1B is a bottom view of the apparatus of FIG. 1A.

FIG. 1C is a cross-sectional view taken along line A-A of FIG. 1Aillustrating a test strip disposed within the testing device.

FIGS. 2A, 2B and 2C are cut-away side views of the apparatus of claim 1in positions during use.

FIG. 3A is a cut-away side view of an alternate preferred embodiment ofthe present invention.

FIG. 3B is a bottom view of the alternate embodiment of FIG. 3Aillustrating test strips disposed within the annular space.

FIG. 4A is a cut-away side view of still another preferred alternativeembodiment of the present invention.

FIG. 4B is a bottom view of the alternative embodiment of FIG. 4Aillustrating a test strip disposed within a groove on the lancet.

FIG. 4C is a bottom view of an alternate embodiment of the lancing andtesting apparatus of the present invention.

FIG. 4D is a bottom view of a further alternate embodiment of theapparatus of the present invention.

FIG. 4E is a bottom view of still a further preferred embodiment of theapparatus of the present invention.

FIG. 4F is a cut-away side view of another preferred embodiment of thepresent invention illustrating a dual lancet apparatus.

FIG. 4G is a cross-sectional end view of the alternate embodiment shownin FIG. 4F.

FIG. 4H is a cut-away side view of another alternate embodiment of thelancet of the present invention.

FIG. 5A is a cut-away side view of still another alternate embodiment ofthe apparatus of the present invention.

FIG. 5B is a side view of the apparatus shown in FIG. 5A disposed in atesting device.

FIG. 6A is a cut-away side view of an alternate embodiment of theapparatus of the present invention.

FIG. 6B is a cut-away side view of the apparatus of FIG. 6A disposedwithin a tissue surface.

FIG. 6C is a cut-away side view illustrating the apparatus of FIG. 6Adisplaying the capillary action of the design.

FIG. 7 is a cut-away side view of an alternate preferred embodiment ofthe apparatus of the present invention.

FIGS. 8A and 8B are cut-away side views of an alternate embodiment ofthe apparatus of the present invention.

FIG. 8C is a disassembled view of the apparatus of FIGS. 8A and 8B.

FIG. 9A is a cut-away side view of an alternate embodiment of theapparatus of the present invention.

FIG. 9B is a disassembled view of the apparatus of FIG. 9A.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated andspecific language will be used to describe the same. It willnevertheless be understood that no limitation of the scope of theinvention is thereby intended, such alterations, modifications, andfurther applications of the principles of the invention beingcontemplated as would normally occur to one skilled in the art to whichthe invention relates.

The present invention provides a device and method for obtaining smallvolume samples of a body fluid. In preferred embodiments the inventioncombines a lancing element integrated with a capillary member in asingle unit for lancing a person's skin and acquiring the body fluidproducing by the lancing. The invention employs a lancing element whichextends within the capillary member, and the body fluid passes throughthe capillary member in the space between the lancing element and theinterior wall of the capillary member. This integrated unit is useful byitself or in combination with other devices which perform complementaryfunctions such as promoting the expression of the body fluid from theincision, collecting and analyzing or testing the fluid. The device maybe a reusable or disposable unit.

In contrast to the prior art, the present invention locates the lancetwithin the capillary such that the capillary is in position, andcentered, over the incision before the lancet is extended to create theincision. This avoids the need for moving the capillary after theincision is made, and consequently reduces the significant difficultiesthat can be encountered in moving a capillary tube quickly andaccurately to the site of an incision. It therefore enhances the abilityto acquire the expressed body fluid without loss, delay orcontamination.

In view of these purposes and advantages, it will be appreciated bythose skilled in the art that the particular mechanisms used to extendand retract the lancet, and to hold the capillary tube, are not criticalto the invention, although certain advantages are obtained with givenembodiments, as hereafter described. Therefore, the underlying conceptforming the basis for the present invention is useful with a widevariety of lancing mechanisms, as are known in the art. For example, thepresent invention is useful in combination with the mechanisms forextending and retracting lancets relative to a housing described, forexample in application PCT/EP01/12527 and U.S. application Ser. No.09/963,967, incorporated herein by reference. The foregoing disclosuresconstitute a part of the description of the present invention and itsavailable design alternatives.

The present invention is useful with various body fluids. For example,the unit is suitable for accessing either blood or interstitial bodyfluid. The device may be readily configured for either fluid bycontrolling the distance by which the lancing member extends into theuser's skin when in the extended position. For example, a depth of 0.5to 2.5 mm will typically produce blood.

In one preferred embodiment, illustrated in FIGS. 1A, 1B and 1C, unit100 comprises a body 105 having associated features to facilitate theuse of the unit. Body 105 is a capillary member having an internaldiameter sized to draw and retain fluid from a contacted source usingcapillary action. Body 105 includes internal structure for supportingthe lancet 120 and for moving the lancet longitudinally between a first,retracted position and a second, extended position. The unit 100 mayalso include means relating to the testing of the body fluid asdescribed hereafter.

Referring to FIG. 1A in detail, there is shown a basic, integrated unit100 for testing body fluids. Apparatus 100 comprises a main body 105,lancet 120 with distal point 135, biasing device 150, and lancet carrieror hub 110. Annular space or void 130 is defined within body 105 anddisposed between the lancet 120 and the internal wall of main body 105.This space is generally referred to herein as an “annular” space,although it will be appreciated that the shape of the space will varydepending on the shapes of the lancet and capillary member and theposition of the lancet within the capillary member.

For purposes herein, the term annular space is to be understood asencompassing generally the space between the capillary member and thecontained lancet, including the variety of physical shapes that thespace between the lancet and the capillary member may assume, dependingat least in part on the noted possible variations. In certain preferredembodiments, the annular space 130 between lancet 120 and main body 105is between 10 and 500 μm, and is preferably between 20 and 200 μm toobtain optimal capillary fill time with blood.

Referring now to FIG. 1B there is shown a bottom view of apparatus 100.FIG. 1B illustrates annular space 130 disposed between lancet 120 andmain body 105. In use, the annular space 130 performs a capillaryfunction in that body fluid is drawn up through apparatus 100 withinannular space 130, with displaced air escaping from the unit through theopposing end of body 105. The body 105 and lancet or lancing element 120are sized and arranged to provide the desired flow of body fluid throughcapillary action. This will depend to some extent on the subject bodyfluid, as well as on other parameters.

In addition, the flow of fluid may be enhanced by forming the lancingmember and/or the interior surface of the capillary member from amaterial which is hydrophilic, which has been treated to be hydrophilic,or which has been coated with a hydrophilic material such as asurfactant or hydrophilic polymers. The surfaces can also be treatedusing polyamides, oxidation (e.g. corona/plasma treatment); plasmachemical vapor deposition; vacuum vapor deposition of metals,metaloxides or non-metaloxides; or deposition of an element whichoxidizes with water. The annular space is therefore sized to provide thedesired flow by capillary action with the various influences being takeninto account.

Optionally an absorbent pad may be placed between the test strip and thedistal end of the capillary passage for wicking body fluid from theannular space to the test strip. In the embodiment where the test stripis disposed within the annular space, no absorbent pad may be neededbecause the test strip will be in direct contact with the body fluid.

The lancing element or lancet 120 is received and longitudinally movablewithin the capillary space 130 of unit 100 between a first, retractedposition, and a second, extended position. Means are provided forresiliently extending and retracting the lancet in order to make adesired incision and to then withdraw the lancet back into a shieldedposition.

Various means for extending a lancet relative to a housing are known inthe art, and are useful in combination with the present invention. Thesedevices, for example, typically include lancets held by carriers thatare spring loaded for movement relative to the surrounding housing.Alternatively, a spring-loaded hammer may be use to impact the lancetcarrier in order to drive it in the direction to lance the skin.Examples of such mechanisms are contained in the following U.S. Pat.Nos. 5,951,492; 5,857,983 and 5,964,718. The foregoing disclosures areincorporated herein by reference, and constitute a part of thedescription of the present invention and its available designalternatives.

These devices typically extend the lancet to a defined extent, such asby moving the lancet to a stop. Such devices frequently are producedwith a predefined limit of travel for the lancet, thereby defining apenetration for the lancet into the skin. Alternatively, devices arewell known which permit the user to adjust the penetration depth, suchas by turning a wheel or other mechanism, with such adjustable devicesfrequently including a dial or other display which indicates theselected depth. These types of mechanisms are useful in combination withthe present invention.

Various means may similarly be employed for retracting the lancet afterit has made the incision, and many such mechanisms are known in the art,including the references previously cited and incorporated herein. Oneexample of a retraction means is spring 150 (FIG. 1) surrounding lancet120 and disposed between bearing surfaces or retainers 107 associatedwith body 105 and bearing surfaces or retainers 122 associated withlancet 120. Preferably bearing surfaces 107 and 122 are fingers, tabs,flanges, rings, or similar structures which provide sufficient bearingsurfaces to retain spring 150 in place without materially impedingcapillary fluid flow.

The resilient means is mounted to provide relative movement to retractthe lancet into the main body after making the incision. Preferably theresilient means, such as spring 150, is made from a biocompatiblematerial, such as metal, plastic, elastic or a similar material known inthe art, which does not react with the sample or interfere with thetesting procedure. The resilient means may allow multiple uses if theunit is to be reused, or may be a disposable or one-use mechanism usedwith disposable or one-use embodiments of the unit.

The resilient means may be placed in various locations without affectingthe operation of the unit. For example, the spring may be placed in thelower portion of the main body (FIG. 1A), in the upper portion of themain body (FIG. 4A), externally of the main body between the body andthe lancet carrier (not shown) or externally in an external structureholding the unit (FIG. 7). In further alternate embodiments, theresilient means can be arranged to provide expansion or contractionforce to move the lancet to its retracted position. Thus, the means forretracting the lancet may, for example, push or pull the lancet to theretracted position.

The withdrawal of the lancet may also be either a full or only a partialwithdrawal. When fully withdrawn, the lancet is removed from theincision and returned to the retracted position protected fromaccidental contact by the user. However, in an alternate approach thelancet could be only partially withdrawn, thereby leaving a portion ofthe lancet remaining within the incision. When the lancet is onlypartially withdrawn, the lancet acts as a focal point for locating theblood and transferring it to the capillary. This may be useful to employthe lancet to assure that the incision remains open for the blood orother body fluid to flow out of the incision.

Referring now to FIG. 1C there is shown a cross-sectional view ofapparatus 100 taken about line A-A of FIG. 1A. Apparatus 100 furtherincludes a testing element, such as reagent test strip 90 and test stripholder 140. Test strip holder 140 is an opening or slot in the wall ofbody 105 allowing test strip 90 to be inserted into apparatus 100 andreceived within annular space 130 such that test strip 90 is disposedradially around lancet 120. Test strip 90 can be held in place duringthe lancet's movement as shown, or it can move longitudinally withlancet 120 during the lancet's extension and retraction, as shown inlater embodiments. Either way, the capillary action of unit 100 drawsthe body fluid into annular space 130 so that the fluid contacts thetest strip.

The body 105 may be made from any suitable material, and typically canbe economically produced from plastics, glass, or various othermaterials, for example by injection molding or extrusion. The main bodymay be manufactured of a transparent material such as glass, plastic,polyvinyl chloride or any similar bio-compatible plastic. Alternatively,the main body may be manufactured having an opaque or solid appearingsurface. In some embodiments it is desirable to have the capillarymember transparent, or to include a window portion to allow the user toobserve the progress of fluid filling the capillary and/or to facilitateviewing the testing of the body fluid, particularly by optical means.

Lancet 120 and spring 150 may be manufactured of any bio-compatiblematerial such as steel, surgical stainless steel, aluminum, or titanium,as well as many other suitable materials known in the art. Preferablylancet 120 is made in a solid piece which is sufficiently sharpened tocreate an incision.

Preferably unit 100 is manufactured in a compact size, with annularspace 130 sized to hold the desired fluid sample size. While the desiredsample size will vary depending on the fluid to be sampled and thespecific test desired, in preferred embodiments the volume is relativelysmall, and may be as small as 3 μL and less, including less than 1 μL.For transport and use, unit 100 may be packaged individually, or may beloaded in a cartridge type of container which may be loaded in anapplicator for conducting multiple tests as desired.

Sterility of the unit may be enhanced by the use of a cap (FIG. 5A) orother sealing member placed over the distal end of the capillary member.In one embodiment, a cap is maintained over the capillary member toenclose the lancet prior to use. The cap is simply removed when the unitis to be used. In an alternate embodiment a plastic piece surrounds thetip and a portion of the plastic is twisted, cut or torn off to exposethe tip for use.

In a further alternate approach, a membrane is positioned over thedistal end of the capillary member to provide a seal for the unit. Themembrane is composed of a suitable material through which the lancet mayextend during use. Thus, the sealing membrane does not have to beremoved for use, but rather is sufficiently thin and penetrable as toremain in place when the lancing member is displaced from the retractedposition to the extended position. In the latter embodiment, the sealingmembrane is preferably biocompatible as well, and should not interferewith the desired functioning of the lancing member to incise the skin orthe resulting capillary fluid flow. One example of such a tip isdisclosed in application PCT/EP01/02198.

Illustrated in use in FIGS. 2A, 2B and 2C, the distal end of apparatus100 is placed over an appropriate incision site, such as a forearm orfingertip such that the distal end abuts the skin surface. This providesa position control to enable application of a predetermined (chosen)pricking depth. In the retracted position, the distal tip 135 of thelancing element is fully received within the unit 100, preventingaccidental contact with the tip. A downward force D (FIG. 2B) is thenapplied to lancet carrier 110, displacing lancet 120 from the static,protected position shown in FIG. 2A, to an extended position, shown inFIG. 2B. In the extended position, tip 135 of lancet 120 penetrates theskin tissue thereby creating a small incision, typically 0.5 to 1.2 mmdeep. The incision depth will typically be pre-set at a desired level,or may be controlled by a selectable depth adjustment mechanism includedon the unit.

The force D is then released from lancet carrier 110, and spring 150biases lancet 120 into the retracted and protected position as shown inFIG. 2C. After retraction, apparatus 100 remains over the newly formedincision, preferably without movement, as shown in FIG. 2C, and bodyfluid F is drawn into annular space 130 of device 100 by capillaryaction. The capillary action is made more efficient since the capillarymember is immediately in place and aligned with the incision, minimizingthe concerns of movement or a gap between the tissue and the capillarymember. A sufficient volume of body fluid F is drawn into annular space130 so that it may be collected, tested and/or analyzed, for example bycontact with test strip 90. In alternate methods of use, additionaltools are used to assist in expressing a sufficient volume of fluid fromthe incision site, as is well known.

Testing of the fluid sample can be accomplished using standard opticalor electrochemical methods. The collected fluid can be analyzed usingthe full range of available procedures and equipment, includingconventional test strip chemistries. For example, in one embodiment,after body fluid F contacts a micro-porous test strip 90, test strip 90may be optically read in place or after removal to determine, forexample, the blood glucose level. An optical reading of the test striptypically compares the color of the reaction of the test strip to acontrol chart. Alternately, test strip 90 may be removed from apparatus100 and connected to or placed in a chemical or electronic testingapparatus. In a further alternate embodiment, unit 100 includes anoptically-readable, reactive coating placed on the surface of lancet 120or the interior circumference of body 150. Testing of body fluid F canbe accomplished by the optical reading of the result of the reaction ofthe coating to the body fluid.

The device in alternate embodiments includes multiple testing means, forexample two or more test strips 90, and includes alternate structuralarrangements. Referring to FIGS. 3A and 3B, an alternative embodiment ofapparatus 100 is shown. Apparatus 300 is similar in construction andmaterials to unit 100 and comprises an outer body 305, lancet 320 havingdistal tip 335, lancet carrier 310, spring 350, spring bearing surfacesor retainers 307 and 322, and annular space 330. As shown in FIG. 3A andwith an upward view in FIG. 3B, apparatus 300 further includes teststrip holders 340 and test strips 90 disposed within annular space 330.In use, body fluid that is drawn into annular space 330 by capillaryaction contacts test strips 90. The multiple test strips 90 can beduplicates to ensure accuracy, or may include different reagents toperform multiple tests simultaneously.

Referring now to FIGS. 4A and 4B there is shown still another embodimentof the apparatus of the present invention. In this embodiment, apparatus400 comprises main body 405, lancet 420, lancet carrier 410, spring 450,spring retention means 407, groove 422 disposed axially along lancet420, and annular space 430. As shown in FIG. 4B, test strip 90 isdisposed within groove 422 in lancet 420. Although lancet 420 is onlyshown as having a single groove 422 and a single test strip 90, lancet420 may include a plurality of grooves and test strips in order toperform the methods of the present invention.

Referring now to FIGS. 4C, 4D and 4E, there are shown alternativeembodiments 400′, 400″ and 400′″ of apparatus 400. As shown in FIG. 4C,lancet 420′ includes first and second grooves 422′, each being adaptedto receive a test strip 90 (not shown). Referring to FIG. 4D, lancet420″ includes grooves 422″ having a V shaped geometry adapted to receivetest strips 90 (not shown). Alternatively, as shown in FIG. 4E, mainbody 405′″ of apparatus 400′″ includes grooves 422′″ adapted to receiveand carry test strips 90 (not shown). Alternately, a reactive coatingcould be deposited in grooves 422′″. In each of the embodimentsillustrated in FIGS. 4C, 4D, and 4E, the apparatus includes each of theman unit elements shown in FIG. 4A.

Referring now to the alternate embodiment in FIGS. 4F and 4G, there isshown apparatus 400F having a main body 405F, first and second lancets420F, annular space 430F, first and second distal lancet tips 435F andchannel 422F formed between first and second lancets 420F. A test strip90F may be disposed within channel 422F thereby placing the test stripin spatial communication with the body fluid as the fluid moves upwardlyinto the capillary. Additionally, as lancets 420F are advanced, the teststrip 90F will also be advanced.

FIG. 4H shows still another alternative embodiment, unit 400H. Lancet420H includes channel 422H disposed therein. Channel 422H may beutilized to advance body fluid to a test strip disposed adjacent to theproximal end of the channel. Alternatively, a test strip 90H is disposedwithin channel 422H.

In still another embodiment, shown in FIGS. 5A and 5B, apparatus 500comprises a main body 505, lancet 520, lancet carrier 510, annular space530 and biasing mechanism 550. In use (not shown), apparatus 500 isdisposed over a site where body fluid is to be sampled, lancet 520 isadvanced within main body 505 by applying a downward force D to lancetcarrier 510. The distal end 535 of lancet 520 pierces the tissue,thereby creating a small incision through which body fluid will flow.Force D is then removed from lancet carrier 510, whereby biasing orresilient mechanism 550 retracts lancet 520 within main body 505. Bodyfluid flows from the incision created by the lancet into annular space530 by capillary action.

After a sufficient amount of body fluid has been drawn into annularspace 530, apparatus 500 is placed into analysis equipment, such asblood glucose measuring device 580 shown in FIG. 5B. The analysisequipment may use optical transmittance, reflectance, flourescence ordirect sampling with electrical and/or chemical stimuli to test thefluid sample in conventional fashion. For example, in a simple testingmachine a blood glucose level is obtained by pressing button 585 onmeasuring device 580, resulting in a blood glucose level displayed ondisplay 590.

In a still further embodiment also illustrated in FIGS. 5A and 5B,electrochemical sensors or electrodes 560 may be located within annularspace 130. The sensors 560 are connected by wires 565 to measuringequipment 580 to perform analysis of the body fluid. The sensors can beconnected to the measuring equipment prior to the fluid acquisition, orunit 100 may be moved and placed in or connected to the measuringequipment.

A further variant on the structure of unit 100 is illustrated in FIGS.6A and 6B. Apparatus 600 comprises main body 605, lancet 620, annularspace 630 and safety cap 618 disposed over the end of main body 605. Inthis embodiment, the lancet 620 is secured to the main body, and doesnot move relative thereto. As shown in FIG. 6A, in apparatus 600 thedistal end 635 of lancet 620 extends slightly beyond the distal end 607of main body 605. Typically, the distance between the distal end 635 oflancet 620 and main body 605 is between 0.05 mm and 2 mm, preferablybetween 0.5 mm and 1.2 mm.

In use as shown in FIG. 6B, after safety cap 618 is removed from thedistal end 607 of main body 605, apparatus 600 is placed over a desiredlocation where body fluid is to be withdrawn, i.e. forearm or fingertip.A force is applied to the proximal end 604 of main body 605, forcing thedistal tip 635 of lancet 620 into the tissue and creating a smallincision through which body fluid will flow. Apparatus 600 is thenslightly retracted from the tissue location, as shown in FIG. 6C,allowing a small drop of body fluid to form and drawing the fluid intoannular space 630 by capillary action. The fluid can then be tested inthe various manners described herein.

A further alternate embodiment is illustrated in FIG. 7 with adisposable unit 700 held in a base 740. Unit 700 includes main body 705with lancet 720 mounted to carrier 710. Main body 705 is preferablyreleasably held by interior wall 745 of base 740 by suitable means, suchas a friction fit (shown) or other coupling. Carrier 710 extends to aninjector member or plunger 760 and may be connected by a friction fit,threaded engagement, form fit, jigsaw fit (such as disclosed inPCT/EP01/12527), a snap or a similar coupling. Spring 750 is mountedbetween bearing surfaces 707 on base 740 and bearing surfaces 722 oninjector 760. In this embodiment, the assembly provides a largergrippable area to facilitate use, while allowing a reusable base andminimizing the internal structure and pieces for a disposable unit 700.Various base unit designs, for example a “pen” injector, can also beused.

An additional preferred embodiment is illustrated in FIGS. 8A, 8B and8C. Device 800 includes a proximal body portion 805 coupled to a distalbody portion 807. Carrier 810 attached to lancet 820 is disposed withinproximal body portion 805 with lancet 820 extending through distal bodyportion 807 to a distal tip. Capillary channel 830 is defined in distalbody portion 807, and defines an annular space extending from the distalend of body portion 807 to a testing element holder 860. Preferablytesting element holder 860 is a side port in body portion 807 forreceiving testing media such as a testing pad 890.

Another preferred embodiment is illustrated in FIGS. 9A and 9C. Device900 includes a proximal body portion 905 coupled to a distal bodyportion 907. Carrier 910 attached to lancet 920 is disposed withinproximal body portion 905. Capillary tube 930 surrounding lancet 920 andan annular space is received within distal body portion 907. Capillary930 extends from the distal end of body portion 907 to a testing elementholder 960. Preferably testing element holder 960 is a slot or side portin body portion 907.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges and modifications that come within the spirit of the inventionare desired to be protected.

1. A device for sampling body fluid, comprising: a) a main body defininga capillary channel; b) a lancet disposed within said capillary channeland defining an annular space between said lancet and said main body; c)wherein said lancet is selectively advancable and retractable; and, d)wherein said capillary channel is dimensioned to draw a body fluid intosaid annular space through capillary action.
 2. The device of claim 1further comprising at least one testing element in communication withsaid annular space.
 3. The device of claim 2 wherein said testingelement is a test strip.
 4. The device of claim 3 wherein said teststrip is a membrane.
 5. The device of claim 3 wherein said test strip isradially mounted around said lancet.
 6. The device of claim 3 whereinsaid test strip is mounted in a groove defined in said lancet.
 7. Thedevice of claim 3 wherein said test strip is mounted in a groove definedin said main body.
 8. The device of claim 2 further comprising two ormore testing elements in communication with said annular space.
 9. Thedevice of claim 2 wherein said testing element comprises electrochemicalsensors within said annular space.
 10. A lancet module, comprising amodule body portion comprising a lancet channel with a plurality oflancet bearing guides disposed within the lancet channel; and a lancetcomprising a sharpened distal tip and shaft portion which is slidablydisposed within the lancet channel and lancet bearing guides with thelancet bearing guides configured to confine a lancet to substantiallylinear axial movement.
 11. The lancet module of claim 10 wherein themodule body portion comprises three 3 lancet bearing guides separatedspatially along the lancet channel with a lancet bearing guide disposedat either end of the lancet channel.
 12. The lancet module of claim 10wherein a longitudinal axis of the lancet channel is substantiallyparallel to a longitudinal axis of the module body portion.
 13. Thelancet module of claim 10 wherein the lancet channel further comprisesat least one flow stop chamber disposed within a distal end portion ofthe lancet channel that has a transverse dimension that is significantlylarger than a transverse dimension of a distally adjacent portion of thelancet channel and a rapid transition in transverse dimension that willinterrupt capillary action from a distal end of the lancet channel. 14.The lancet module of claim 10 wherein the module body portion isconfigured to be mechanically registered and secured adjacent a lancetdriver.
 15. A lancet module, comprising a module body portion comprisinga lancet channel having at least one flow stop chamber disposed within adistal end portion of the lancet channel that has a transverse dimensionthat is significantly larger than a transverse dimension of a distallyadjacent portion of the lancet channel and a rapid transition intransverse dimension that will interrupt capillary action from a distalend of the lancet channel; and a lancet comprising a sharpened distaltip and shaft portion which is slidably disposed within the lancetchannel.
 16. The lancet module of claim 15 wherein the lancet channelfurther comprises at least one lancet bearing guide with the lancetbearing guides configured to confine the lancet to substantially linearaxial movement.
 17. The lancet module of claim 15 wherein the modulebody portion comprises three 3 lancet bearing guides separated spatiallyalong the lancet channel with a lancet bearing guide disposed at eitherend of the lancet channel.
 18. The lancet module of claim 15 wherein alongitudinal axis of the lancet channel is substantially parallel to alongitudinal axis of the module body portion.
 19. The lancet module ofclaim 15 wherein the module body portion is configured to bemechanically registered and secured adjacent a lancet driver.
 20. Asampling module, comprising a module body portion comprising a lancetchannel with a plurality of lancet bearing guides disposed within thelancet channel; a lancet comprising a sharpened distal tip and shaftportion which is slidably disposed within the lancet channel and lancetbearing guides with the lancet bearing guides configured to confine alancet to substantially linear axial movement; and a sample reservoir influid communication with a sample input port of the module body portion.21. The sampling module of claim 20 wherein the module body portioncomprises three 3 lancet bearing guides separated spatially along thelancet channel with a lancet bearing guide disposed at either end of thelancet channel.
 22. The sampling module of claim 20 wherein alongitudinal axis of the lancet channel is substantially parallel to alongitudinal axis of the module body portion.
 23. The sampling module ofclaim 20 wherein the lancet channel further comprises at least one flowstop chamber disposed within a distal end portion of the lancet channelthat has a transverse dimension that is significantly larger than atransverse dimension of a distally adjacent portion of the lancetchannel and a rapid transition in transverse dimension that willinterrupt capillary action from a distal end of the lancet channel. 24.The sampling module of claim 20 wherein the module body portion isconfigured to be mechanically registered and secured adjacent a lancetdriver.
 25. A sampling module, comprising: a module body portioncomprising a lancet channel having at least one flow stop chamberdisposed within a distal end portion of the lancet channel that has atransverse dimension that is significantly larger than a transversedimension of a distally adjacent portion of the lancet channel and arapid transition in transverse dimension that will interrupt capillaryaction from a distal end of the lancet channel; a lancet comprising asharpened distal tip and shaft portion which is slidably disposed withinthe lancet channel; and a sample reservoir in fluid communication with asample input port of the module body portion.
 26. The sampling module ofclaim 25 wherein the lancet channel further comprises at least onelancet bearing guide with the lancet bearing guides configured toconfine the lancet to substantially linear axial movement.
 27. Thesampling module of claim 25 wherein the module body portion comprisesthree 3 lancet bearing guides separated spatially along the lancetchannel with a lancet bearing guide disposed at either end of the lancetchannel.
 28. The sampling module of claim 25 wherein a longitudinal axisof the lancet channel is substantially parallel to a longitudinal axisof the module body portion.
 29. The sampling module of claim 25 whereinthe module body portion is configured to be mechanically registered andsecured adjacent a lancet driver.
 30. A sampling module, comprising: amodule body portion comprising a lancet channel; a lancet comprising asharpened distal tip and shaft portion which is slidably disposed withinthe lancet channel of the module body portion; a sample reservoir havingan input end and a terminal end, the sample reservoir being in fluidcommunication with a sample input port of the module body portion; and avent disposed between and in fluid communication with the terminal endof the sample reservoir and the lancet channel.
 31. The sampling moduleof claim 30 wherein a longitudinal axis of the lancet channel issubstantially parallel to a longitudinal axis of the module bodyportion.
 32. The sampling module of claim 30 wherein the module bodyportion is configured to be mechanically registered and secured adjacenta lancet driver.
 33. The sampling module of claim 30 wherein theterminal end further comprises a fill detector.
 34. The sampling moduleof claim 33 wherein the fill detector is electrical.
 35. The samplingmodule of claim 33 wherein the fill detector is optical.
 36. Thesampling module of claim 33 wherein the fill detector is visual.
 37. Asampling module comprising: a module body portion having a sampling siteadjacent a lancet exit port where the sharpened distal tip of the lancetexits a distal end of the module body portion that includes a samplecavity in a distal end surface of the module body portion; a lancetcomprising a sharpened distal tip and shaft portion which is slidablydisposed within the module body portion and extendable from the lancetexit port; and a sample reservoir in fluid communication with a samplecavity of the module body portion.
 38. The sampling module of claim 37wherein a transverse dimension of the sampling cavity is about 2 toabout 5 times a transverse dimension of the lancet shaft portion andwherein a sample flow channel is disposed between and in fluidcommunication with the sample reservoir and the sample cavity.
 39. Thesampling module of claim 37 wherein the module body portion isconfigured to be mechanically registered and secured adjacent a lancetdriver.
 40. A sampling module, comprising: a module body portionconfigured to be mechanically registered and secured adjacent a lancetdriver; a lancet comprising a sharpened distal tip and shaft portionwhich is slidably disposed within the module body portion; and a samplereservoir in fluid communication with a sample input port of the modulebody portion that has a fill detector for determining when the samplereservoir is full of a sample.
 41. The sampling module of claim 40wherein the fill detector is electrical.
 42. The sampling module ofclaim 40 wherein the fill detector is optical.
 43. The sampling moduleof claim 40 wherein the fill detector is visual.
 44. A sampling module,comprising: a module body portion comprising a lancet channel; a lancetcomprising a sharpened distal tip and shaft portion which is slidablydisposed within the lancet channel of the module body portion; a firstsample reservoir having an input end and a terminal end, the input endof the sample reservoir being in fluid communication with a sample inputport of the module body portion; and a second sample reservoir having aninput end in fluid communication with the terminal end of the firstsample reservoir and having a cross sectional area that is substantiallysmaller than a cross sectional area of the first sample reservoir suchthat a sample flowing from the sample input port into the first samplereservoir will fill the first sample reservoir and then rapidly fill thesecond sample reservoir by capillary action.
 45. The sampling module ofclaim 44 wherein a terminal end of the second sample reservoir furthercomprises a fill detector.
 46. The sampling module of claim 45 whereinthe fill detector is electrical.
 47. The sampling module of claim 45wherein the fill detector is optical.
 48. The sampling module of claim45 wherein the fill detector is visual.
 49. A lancet module comprising amodule body portion configured to be mechanically registered and securedadjacent a lancet driver; and a lancet comprising a sharpened distal tipand shaft portion which is slidably disposed within the module bodyportion.
 50. The lancet module of claim 49 wherein the sharpened distaltip of the lancet is covered by the module body portion when the lancetis in a retracted position and the sharpened distal tip extending beyonda distal end of the lancet module when the lancet is in an extendedposition.
 51. The lancet module of claim 49 wherein the module bodyportion is comprised of a polymer.
 52. The lancet module of claim 49wherein the module body portion is comprised of PMMA.
 53. The lancetmodule of claim 49 wherein the module body portion is substantiallyrectangular in shape and comprises a recess configured to be engaged bya ratchet drive mechanism
 54. The lancet module of claim 49 wherein themodule body portion further comprises a lancet drive head slot disposedbetween a first protective strut and a second protective strut of themodule body portion.
 55. The lancet module of claim 54 wherein the firstand second protective struts comprise elongated protective strutsextending substantially parallel to the lancet.
 56. A lancet modulecomprising a module body portion having a lancet channel and a lancetslidably disposed within the lancet channel and a cover sheet disposedover the lancet and lancet channel capturing the lancet shaft in thelancet channel.
 57. The lancet module of claim 56 wherein a sharpeneddistal tip of the lancet is covered by the module body portion when thelancet is in a retracted position and the sharpened distal tip extendingbeyond a distal end of the lancet module when the lancet is in anextended position.
 58. The lancet module of claim 56 wherein the modulebody portion is comprised of a polymer.
 59. The lancet module of claim56 wherein the module body portion is comprised of PMMA.
 60. The lancetmodule of claim 56 wherein the module body portion is substantiallyrectangular in shape and comprises a recess configured to be engaged bya ratchet drive mechanism.
 61. A sampling module comprising: a modulebody portion configured to be mechanically registered and securedadjacent a lancet driver; a lancet comprising a sharpened distal tip andshaft portion which is slidably disposed within the module body portion;and a sample reservoir in fluid communication with a sampling site ofthe module body portion.
 62. The sampling module of claim 61 wherein thesharpened distal tip of the lancet exits a distal end of the module bodyportion at a lancet exit port and the sample reservoir is in fluidcommunication with the lancet exit port.
 63. The sampling module ofclaim 61 wherein the sample reservoir comprises a analytical regionhaving sample sensors disposed within the analytical region.
 64. Thesampling module of claim 63 further comprising sensor contacts inelectrical communication with the sample sensors disposed within theanalytical region.
 65. The sampling module of claim 61 wherein thesharpened distal tip of the lancet is covered by the module body portionwhen the lancet is in a retracted position and the sharpened distal tipextending beyond a distal end of the lancet module when the lancet is inan extended position.
 66. The sampling module of claim 61 wherein themodule body portion is comprised of a polymer.
 67. The sampling moduleof claim 61 wherein the module body portion is comprised of PMMA. 68.The sampling module of claim 61 wherein the module body portion issubstantially rectangular in shape and comprises a recess configured tobe engaged by a ratchet drive mechanism.
 69. A sampling modulecomprising: a module body portion; a lancet comprising a sharpeneddistal tip and shaft portion which is slidably disposed within a lancetchannel of the module body portion; and a sample reservoir which has ananalytical region with sample sensors disposed within the analyticalregion the sample reservoir being in fluid communication with a samplingsite of the module body portion.
 70. A sampling module comprising amodule body portion having a lancet channel, a lancet slidably disposedwithin the lancet channel, a cover sheet disposed over the lancet andlancet channel capturing the lancet shaft in the lancet channel, and asample reservoir for collection of a sample obtained by lancing apatient with the lancet.
 71. The sampling module of claim 70 wherein thesharpened distal tip of the lancet exits a distal end of the module bodyportion at a lancet exit port and the sample reservoir is in fluidcommunication with the lancet exit port.
 72. The sampling module ofclaim 71 further comprising a sample input cavity in a distal endsurface of the module body portion that a transverse dimension that isabout 2 to about 5 times a transverse dimension of the lancet shaftportion and wherein a sample flow channel is disposed between and influid communication with the sample reservoir and the cavity.
 73. Thesampling module of claim 70 wherein the sample reservoir comprises aanalytical region having sample sensors disposed within the analyticalregion.
 74. The sampling module of claim 73 further comprising sensorcontacts in electrical communication with the sample sensors disposedwithin the analytical region.
 75. The sampling module of claim 70wherein a sharpened distal tip of the lancet is covered by the modulebody portion when the lancet is in a retracted position and thesharpened distal tip extending beyond a distal end of the lancet modulewhen the lancet is in an extended position.
 76. The sampling module ofclaim 70 wherein the module body portion is comprised of a polymer. 77.The sampling module of claim 70 wherein the module body portion iscomprised of PMMA.
 78. The sampling module of claim 70 wherein themodule body portion is substantially rectangular in shape and comprisesa recess configured to be engaged by a ratchet drive mechanism.
 79. Thesampling module of claim 70 wherein the sample reservoir furthercomprises thermal sensors for detecting the presence of a sample.
 80. Asampling device comprising: a lancet for obtaining a blood sample from auser, said lancet having a distal end and a proximal end; a reservoirfor collecting the blood sample adjacent to the distal end of saidlancet; a lancet driver attached to the proximal end of said lancet; anda sensor on said sampling device for detecting said user and initiatinga lancing cycle.
 81. A sampling device according to claim 80 whereinsaid reservoir further comprises an analytical region having samplesensors for analyzing the blood sample.
 82. A sampling device accordingto claim 81 wherein said lancet and said reservoir are integrated into adisposable cartridge.
 83. A sampling device according to claim 80wherein a user sensor detects said user activates the lancet driver. 84.A sampling device according to claim 83 wherein the user sensor isprompted when said disposable cartridge is loaded into said device. 85.A sampling device according to claim 80 wherein the user sensorcomprises an electric circuit, which is closed when pressured, isapplied by said user on said sensor.
 86. A method of samplingcomprising: providing a sampling module having a lancet disposed withina lancet channel, a sample reservoir and an orifice on a surface of thesampling module in fluid communication with the sample reservoir;coupling the lancet of the sampling module to a lancet driver;activating a lancing cycle by having a patient place target tissue overa sensor which detects the target tissue and initiates the lancingcycle; lancing the target tissue to obtain a sample of blood; collectingsaid sample of blood through the orifice.
 87. The method of claim 86further comprising informing the patient to remove the target tissuefrom the ergonomically contoured active sampling area.
 88. A method ofsampling comprising: loading a disposable sampling module into a lancingdevice with a lancet disposal within a lancet channel which has anorifice on a surface of said sampling module; initiating a lancing cycleby prompting a user sensor on said lancing device; activating saidlancing cycle by having a patient place a finger over an ergonomicallycontoured area located on said surface such that said finger overlapswith said orifice; lancing the finger to obtain a sample of blood;collecting said sample of blood through said orifice; and informing saiduser to remove said finger from the ergonomically contoured activesampling area.
 89. The method of claim 88 further comprisingtransferring the sampling module for analysis after the sample of bloodhas been obtained.
 90. A method of sampling comprising: loading adisposable sampling module having a lancet into a lancing device;initiating a lancing cycle and activating a user sensor on said lancingdevice by placing a piece of skin on a surface of said sampling module;lancing said skin to obtain a blood sample; and collecting said bloodsample.
 91. The method of claim 90 further comprising transferring thesample module for analysis after the blood sample has been obtained. 92.A method of sampling comprising: loading a disposable sampling modulehaving a lancet into a lancing device; initiating a lancing cycle andactivating a user sensor on said lancing device by placing a piece ofskin on a surface of said sampling module; lancing said skin to obtain ablood sample; collecting said blood sample; and.
 93. The method of claim92 further comprising transferring the sampling module for analysisafter the blood sample has been obtained.
 94. A method of samplingaccording to claim 92 further comprising analyzing said blood sample.95. A tissue penetration sampling device for collecting blood from theskin of a patient, the device comprising: a sampling module having asampling site, the sampling site having a sample input port, a samplereservoir in fluid communication with the sample input port, a lancetmaintained within the sampling module, the lancet having a lancet tipadjacent the sample input port, and a lancet driver coupled to thelancet to drive the lancet tip through the opening to lance the skinwhen the lancet driver is actuated, the device being configured to allowactuation of the lancet driver, lancing of the skin, collection of theblood, and movement of the blood to the sample reservoir seamlessly byforming a substantially airtight seal at the opening when the skin isfirmly pressed against the sampling site.
 96. The device of claim 95further comprising a pierceable membrane disposed over the sample inputport and the lancet tip and configured to allow the tip of the lancet topass through the pierceable membrane during a lancing cycle.
 97. Asampling module for use in collecting blood from the skin of a patient,comprising a body portion, a sampling site on the body portion defininga sample input port, the sampling site shaped to conform to the skin andto form a substantially airtight seal with the skin, a lancet disposedin the body portion, the lancet having a lancet tip adjacent the sampleinput port, wherein the lancet is operable to send the lancet tipthrough the opening to lance the skin of the patient, and a reservoir influid communication with the sample input port, the sampling acquisitionmodule configured to allow seamless sampling of the blood, andintegrated lancing of the skin, collection of the blood through thesample input port, and movement of the blood to the sample reservoir.98. A method of collecting blood from the skin of a patient, the methodcomprising: a) contacting the skin of the patient with a blood samplingdevice, and b) performing a single initiating act resulting in the bloodsampling device lancing the skin, collecting blood from the skin, andmoving blood to a reservoir within the sampling device.
 99. The methodof claim 98, wherein the single initiating act also results in analysisof the blood.
 100. The method of claim 99, wherein the single initiatingact also results in display of information obtained from the analysis ofthe blood.
 101. The method of claim 98, wherein the blood is collectedand stored seamlessly.
 102. A sampling module belt comprising aplurality of sampling modules having a module body portion with a lancetchannel and a lancet slidably disposed within the lancet channel and acover sheet disposed over the lancet and lancet channel capturing thelancet shaft in the lancet channel with the plurality of samplingmodules interconnected in a linear array by a flexible belt member. 103.The sampling module belt of claim 102 wherein the flexible belt membercomprises the cover sheet that extends across at least a portion of thefront surface of the module body portions.
 104. The sampling module beltof claim 102 wherein the belt member comprises a single sheet of coversheet material.
 105. A lancet belt cartridge comprising: (a) a lancetbelt comprising a plurality of lancets releasably secured to a flexiblebelt tape substantially orthogonal to a longitudinal axis of the belttape; and (b) a supply canister disposed about an unused portion of thelancet belt.
 106. The lancet belt cartridge of claim 105 furthercomprising a receptacle canister configured to accept and store usedlancets.
 107. A lancet module cartridge, comprising a plurality oflancet modules interconnected in an array and configured for sequentialuse.
 108. A lancet module cartridge comprising: (a) a lancet module beltcomprising a plurality of lancet modules interconnected in an array by aflexible member; and (b) a supply canister that is disposed about anunused portion of the lancet module belt.
 109. The lancet modulecartridge of claim 108 further comprising a receptacle canister that isconfigured to store a used portion of the lancet module belt.
 110. Alancet module cartridge comprising: (a) a lancet module belt comprisinga plurality of lancet modules having a module body portion with a lancetchannel and a lancet slidably disposed within the lancet channel and acover sheet disposed over the lancet and lancet channel capturing thelancet shaft in the lancet channel with the plurality of lancet modulesinterconnected in a linear array by a flexible belt member. (b) a supplycanister that is disposed about an unused portion of the lancet modulebelt; and (c) a receptacle canister that is configured to store a usedportion of the lancet module belt.
 111. A sampling module cartridgecomprising a plurality of sampling modules interconnected in an arrayand configured for sequential use.
 112. The sampling module cartridge ofclaim 111 wherein at least one of the sampling modules comprises asample reservoir having an analytical site with sample sensors forsample testing.
 113. A sampling module cartridge comprising: (a) aplurality of sampling modules interconnected in an array by a flexiblemember; and (b) a supply canister that is disposed about an unusedportion of the sampling module belt.
 114. The sampling module cartridgeof claim 113 further comprising a receptacle canister that is configuredto store a used portion of the sampling module belt.
 115. The samplingmodule cartridge of claim 113 wherein at least one of the samplingmodules comprises a sample reservoir having an analytical site withsample sensors for sample testing.
 116. A sampling module cartridgecomprising: (a) a sampling module belt comprising a plurality ofsampling modules having a module body portion with a lancet channel, alancet slidably disposed within the lancet channel, a cover sheetdisposed over the lancet and lancet channel capturing the lancet shaftin the lancet channel, and a sample reservoir for collection of a sampleobtained by lancing a patient with the lancet with the plurality ofsampling modules interconnected in a linear array by a flexible beltmember; (b) a supply canister that is disposed about an unused portionof the sampling module belt; and (c) a receptacle canister that isconfigured to store a used portion of the sampling module belt.
 117. Anapparatus for collecting blood from a patient's skin, the apparatuscomprising a cartridge including a plurality of sampling modules, eachsampling module comprising a sampling input port, a lancet having a tip,the tip adjacent the sampling input port, the lancet maintained withinthe cartridge and operable to extend the lancet tip through the samplinginput port to pierce the patient's skin positioned adjacent the samplinginput port, and an analytical region in fluid communication with thesampling input port, the analytical region associated with samplesensors.
 118. The apparatus of claim 117, wherein the cartridge includesat least 10 sampling modules.
 119. The apparatus of claim 117, whereineach sampling module is configured to allow integrated lancing,collection, and testing.
 120. A method of collecting and testing aseries of blood samples, the method comprising: a) providing a samplingmodule cartridge and a reader device, the sampling module cartridgeincluding a plurality of sampling modules, each sampling module adaptedto perform a single blood sampling cycle of lancing, collection of ablood sample, and testing of the blood sample; b) coupling the samplingmodule cartridge to the reader device; c) initiating the blood samplingcycle and obtaining a first blood sample; d) testing the first bloodsample obtained; e) advancing the sampling cartridge to bring anothersampling module online; f) initiating another blood sampling cycle andobtaining a second blood sample; and g) testing the second blood sample.121. The method of claim 120 further comprising repeating steps e)through g) until substantially all sampling modules on the samplingmodule cartridge have been used.
 122. The method of claim 121 furthercomprising uncoupling the sampling module cartridge and reader deviceafter substantially all sampling modules on the sampling modulecartridge have been used.
 123. The method of claim 122, wherein steps e)through g) may be repeated at least 10 times before uncoupling thesampling module cartridge and reader device.
 124. The method of claim120, wherein each sampling module is configured to allow integratedlancing, collection, and testing.
 125. The method of claim 120, whereineach sampling module is configured to allow a measurement to be obtainedby the reader device.
 126. A tissue penetration sampling devicecomprising a controllable lancet driver operatively coupled to acartridge of sampling modules.
 127. A sampling module cartridgecomprising a plurality of sampling modules disposed within a cartridgehousing and configured for serial use by a lancet driver.
 128. Thesampling module cartridge of claim 127 wherein at least one of thesampling modules comprises a sample reservoir having an analytical sitewith sample sensors for sample testing.
 129. The sampling modulecartridge of claim 127 wherein the plurality of sampling modulescomprise a sampling module belt comprising a plurality of samplingmodules having a module body portion with a lancet channel and a lancetslidably disposed within the lancet channel and a cover sheet disposedover the lancet and lancet channel capturing the lancet shaft in thelancet channel with the plurality of sampling modules interconnected ina linear array by a belt member.
 130. A cartridge for use in sampling,comprising a sampling cartridge body having a plurality of samplingmodule portions, a lancet cartridge body having a plurality of lancetmodule portions with the sampling cartridge body and lancet cartridgebody being disposed adjacent each other in an operative configurationsuch that each lancet module portion can be readily aligned in afunctional arrangement with each sampling module portion.
 131. Thecartridge of claim 130 wherein each sampling module portion comprises asample reservoir, a lancet channel and an input port wherein the lancetchannel is disposed between and in fluid communication with the inputport and the sample reservoir and may serve as a sample flow channel.132. The cartridge of claim 130 wherein each lancet module portioncomprises a lancet channel with a lancet slidably disposed in the lancetchannel.
 133. The cartridge of claim 130 wherein each sampling moduleportion comprises a separate sampling module connected to adjacentsampling module portions by a flexible belt.
 134. The cartridge of claim130 wherein the lancet module portions comprise separate lancet modulesconnected to adjacent lancet modules by a flexible belt.
 135. Thecartridge of claim 130 wherein the lancet cartridge body is removablyconnected to the sampling cartridge body.
 136. The cartridge of claim130 wherein the sampling module portions may be readily aligned in afunctional arrangement with the lancet module portions with singledegree of freedom motion between the sampling cartridge body and lancetcartridge body.
 137. The cartridge of claim 130 further comprising acartridge housing with the lancet cartridge body and sampling cartridgebody being disposed within the cartridge housing and being separatelyremovable from the cartridge housing.
 138. The cartridge of claim 130wherein the sampling cartridge body comprises a solid body with eachsampling module portion disposed in fixed relation to the other samplingmodule portions in the solid body.
 139. The cartridge of claim 130wherein the lancet cartridge body comprises a solid body with eachlancet module portion disposed in fixed relation to the other lancetmodule portions in the solid body.
 140. The cartridge of claim 139wherein the lancet cartridge body is substantially cylindrical inconfiguration having a longitudinal axis and each lancet module portioncomprises a lancet channel that is substantially aligned in parallelwith the longitudinal axis of the cartridge body.
 141. The cartridge ofclaim 130 wherein each sampling module portion comprises a samplereservoir having sample sensors for testing a sample disposed therein.142. The cartridge of claim 141 wherein the sample sensors are inelectrical communication with sensor contacts that are configured tomake contact with sensor contact brushes of an analytical reader device.143. The cartridge of claim 130 wherein each sampling module portioncomprises a sample reservoir having sample sensors for detecting thepresence of a sample disposed therein.
 144. The cartridge of claim 130wherein the sampling module portions comprise sample reservoirs toaccept fluid samples.
 145. The cartridge of claim 144 wherein the samplereservoirs comprise an optically transmissive cover sheet disposed overthe sample reservoirs.
 146. The cartridge of claim 145 furthercomprising an optical sensor configured to transmit an optical signalthrough the cover sheet disposed over sample reservoirs of the samplingmodule portions and receive an optical signal from a sample disposedwithin the sample reservoirs.
 147. A skin penetrating system,comprising: a housing member; a plurality of penetrating memberspositioned in the housing member, and a plurality of analyte detectingmembers each associated with a penetrating member, each analytedetecting member including a sample chamber and an opening for transportof a body fluid into the sample chamber, the analyte detecting memberbeing configured to determine a concentration of an analyte in a bodyfluid using a sample of less than 1 μL of a body fluid disposed in thesample chamber; and a user interface configured to relay at least oneof, skin penetrating performance or a skin penetrating setting.
 148. Thesystem of claim 147, wherein the user interface is configured to providea user with at least one input selected from, depth of a penetratingmember penetration, velocity of a penetrating member, a desired velocityprofile, a velocity of a penetrating member into the target tissue,velocity of the penetrating member out of the target tissue, dwell timeof the penetrating member in the target tissue, and a target tissuerelaxation parameter.
 149. The system of claim 147, wherein the userinterface provides at least one output to the user selected from, numberof penetrating members available, number of penetrating members used,actual depth of penetrating member penetration on a target tissue,stratum corneum thickness, force delivered on a target tissue, energyused by a penetrating member driver to drive a penetrating member intothe target tissue, dwell time of the penetrating member, battery status,system status, consumed energy, speed profile of a penetrating member,information relative to contact of a penetrating member with targettissue before penetration by the penetrating member, and informationrelative to a change of speed of a penetrating member as in travels inthe target tissue.
 150. A skin penetrating system, comprising: a housingmember; a plurality of penetrating members positioned in the housingmember, a penetrating member driver coupled to the plurality ofpenetrating members; a plurality of analyte detecting members eachassociated with a penetrating member, each analyte detecting memberincluding a sample chamber and an opening for transport of a body fluidinto the sample chamber, the analyte detecting member being configuredto determine a concentration of an analyte in a body fluid using asample of less than 1 μL of a body fluid disposed in the sample chamber;and a human interface providing at least one output.
 151. A tissuepenetrating system, comprising: a penetrating member driver; a cartridgewith a distal port and a proximal port and coupled to the penetratingmember driver; an analyte detecting member coupled to a sample chamber,the analyte detecting member being configured to determine aconcentration of an analyte in a body fluid using a sample of less than1 μL of a body fluid disposed in the sample chamber; a penetratingmember with a sharpened distal tip and shaft portion that is slidablydisposed within the cartridge, wherein a tip of the penetrating memberis configured to extend through the opening of the sample chamber; and auser interface configured to relay at least one of, skin penetratingperformance or a skin penetrating setting.
 152. The system of claim 151,wherein the user interface is configured to provide a user with at leastone input selected from, depth of a penetrating member penetration,velocity of a penetrating member, a desired velocity profile, a velocityof a penetrating member into the target tissue, velocity of thepenetrating member out of the target tissue, dwell time of thepenetrating member in the target tissue, and a target tissue relaxationparameter.
 153. The system of claim 151, wherein the user interfaceprovides at least one output to the user selected from, number ofpenetrating members available, number of penetrating members used,actual depth of penetrating member penetration on a target tissue,stratum corneum thickness, force delivered on a target tissue, energyused by a penetrating member driver to drive a penetrating member intothe target tissue, dwell time of the penetrating member, battery status,system status, consumed energy, speed profile of a penetrating member,information relative to contact of a penetrating member with targettissue before penetration by the penetrating member, and-informationrelative to a change of speed of a penetrating member as in travels inthe target tissue.
 154. The system of claim 151, further comprising: adata interface configured to couple the tissue penetrating system to atleast one of, support equipment with a data interface and the internet.155. The system of claim 151, wherein the support equipment is selectedfrom at least one of, a base station, home computer, central server, andmain processing equipment for storing glucose level information. 156.The system of claim 151, further comprising: a user interface processorcoupled to the user interface.
 157. A tissue penetrating system,comprising: a penetrating member driver; a cartridge with a distal portand a proximal port and coupled to the penetrating member driver; ananalyte detecting member coupled to a sample chamber, the analytedetecting member being configured to determine a concentration of ananalyte in a body fluid using a sample of less than 1 μL of a body fluiddisposed in the sample chamber; a penetrating member with a sharpeneddistal tip and shaft portion that is slidably disposed within thecartridge, wherein a tip of the penetrating member is configured toextend through the opening of the sample chamber; and a human interfaceproviding at least one output.
 158. The system of claim 157, wherein theat least one output is selected from, a penetration event of apenetrating member, number of penetrating members remaining, time ofday, alarm, penetrating member trajectory waveform profile information,force for last penetration event, the last penetration event, how or lowbattery status, analyte status, time to change cassette status, jammingmalfunction, and system status.
 159. The system of claim 157, whereinthe human interface is selected from an LED, an LED digital display, anLCD display, a sound generator, a buzzer, and a vibrating device. 160.The system of claim 157, wherein the housing is selected from at leastone of, a telephone, a watch, a PDA, electronic device, medical device,point of care device and a decentralized diagnostic device.
 161. Thesystem of claim 157, further comprising: an input device coupled to thehousing, the input device selected from one or more pushbuttons, a touchpad independent of the display device, or a touch sensitive screen on avisual display.
 162. The system of claim 157, further comprising: a dataexchange device for coupling the tissue penetrating system to supportequipment.
 163. The system of claim 162, further comprising: a datainterface configured to couple the tissue penetrating system to supportequipment with a data interface.
 164. A skin penetrating system,comprising: a housing member; a penetrating member positioned in thehousing member, and an analyte detecting member coupled to a samplechamber, the analyte detecting member being configured to determine aconcentration of an analyte in a body fluid using a sample of less than1 μL of a body fluid disposed in the sample chamber, wherein a tip ofthe penetrating member is configured to extend through an opening of thesample chamber.
 165. The system of claim 164, further comprising: aplurality of cartridges integrated in a cassette.
 166. The system ofclaim 165, wherein each cartridge has an exit port, and upon launch eachpenetrating member exists from the exit port.
 167. The system of claim164, further comprising: a tissue stabilizer device coupled to thehousing.
 168. The system of claim 167, wherein the tissue stabilizerdevice is configured to enhance fluid flow from a target tissue. 169.The system of claim 167, wherein the tissue stabilizer device creates astretching of a skin surface.
 170. The system of claim 167, wherein thetissue stabilizer device is configured to apply a force to a targettissue and cause the target tissue to press in an inward directionrelative to the housing member.
 171. The system of claim 167, whereinthe tissue stabilizing member applies a stimulation to a target tissue.172. The system of claim 164, further comprising: a seal formed by afracturable material between the penetrating member and a cartridge, theseal being positioned at least one of a distal port or a proximal portof the cartridge.
 173. The system of claim 164, wherein each penetratingmember is an elongated member without molded attachments.
 174. Thesystem of claim 164, further comprising, a belt for holding thepenetrating members in an array configuration.
 175. The system of claim164, further comprising: a tape device configured to hold thepenetrating members in an array configuration.
 176. The system of claim164, further comprising: a cog configured to hold the penetratingmembers in an array configuration.
 177. The system of claim 164, furthercomprising: a plurality of connectors between penetrating members forholding the penetrating members in an array configuration.
 178. Thesystem of claim 164, further comprising: a support structure forreceiving the penetrating members.
 179. The system of claim 178 whereinthe support structure is a bandolier.
 180. The system of claim 178,wherein the support structure is a drum.
 181. A skin penetrating system,comprising: a housing member; a plurality of penetrating memberspositioned in the housing member, and a plurality of analyte detectingmembers each associated with a penetrating member and a sample chamber,the analyte detecting member being configured to determine aconcentration of an analyte in a body fluid using a sample of less than1 μL of a body fluid disposed in the sample chamber, wherein a tip ofthe penetrating member is configured to extend through an opening of asample chamber.
 182. A tissue penetrating system, comprising: apenetrating member driver; a cartridge with a distal port and a proximalport and coupled to the penetrating member driver; an analyte detectingmember coupled to a sample chamber, the analyte detecting member beingconfigured to determine a concentration of an analyte in a body fluidusing a sample of less than 1 μL of a body fluid disposed in the samplechamber; and a penetrating member with a sharpened distal tip and shaftportion that is slidably disposed within the cartridge, wherein a tip ofthe penetrating member is configured to extend through the opening ofthe sample chamber.
 183. A tissue penetrating system, comprising: apenetrating member driver; a cartridge with a distal port and a proximalport and coupled to the penetrating member driver; an analyte detectingmember coupled to a sample chamber, the analyte detecting member beingconfigured to determine a concentration of an analyte in a body fluidusing a sample of less than 1 μL of a body fluid disposed in the samplechamber; a penetrating member with a sharpened distal tip and shaftportion that is slidably disposed within the cartridge, wherein a tip ofthe penetrating member is configured to extend through the opening ofthe analyte detecting member; and a first seal formed at the distal portand a second seal formed at the proximal port, wherein the first sealand second seal maintain the distal tip of the penetrating member andthe sample chamber in a sterile environment prior to launch of thepenetrating member.
 184. The system of claim 183, further comprising: auser interface configured to relay at least one of, skin penetratingperformance or a skin penetrating setting.
 185. The system of claim 183,further comprising: a human interface providing at least one output.186. A tissue penetrating system, comprising: a cartridge with a distalport and a proximal port, each cartridge including an analyte detectingmember coupled to a sample chamber, the analyte detecting member beingconfigured to determine a concentration of an analyte in a body fluidusing a sample of less than 1 μL of a body fluid disposed in the samplechamber; a penetrating member with a sharpened distal tip and shaftportion that is slidably disposed within the cartridge; a first sealcovering the distal port; and a second seal covering the proximal port187. The system of claim 186, further comprising: a user interfaceconfigured to relay at least one of, skin penetrating performance or askin penetrating setting.
 188. The system of claim 186, furthercomprising: a human interface providing at least one output.
 189. Atissue penetrating system, comprising: a plurality of penetratingmembers each having a sharpened distal tip; a penetrating member drivercoupled to the plurality of penetrating members; and a plurality ofcartridges each housing a penetrating member and configured so that thepenetrating member driver engages each of the penetrating memberssequentially, each cartridge including an analyte detecting membercoupled to a sample chamber, the analyte detecting member beingconfigured to determine a concentration of an analyte in a body fluidusing a sample of less than 1 μL of a body fluid disposed in the samplechamber.
 190. The system of claim 189, wherein each cartridge has aplurality of seals positioned so that the sharpened distal tip remainsin a sterile environment before launch of a penetrating member, theplurality of modules coupled together in an array.
 191. The system ofclaim 189, further comprising: a penetrating member sensor coupled tothe plurality of penetrating members, the penetrating member sensorconfigured to provide information relative to a depth of penetration ofa penetrating member through a skin surface.
 192. The system of claim189, further comprising: a user interface configured to relay at leastone of, skin penetrating performance or a skin penetrating setting. 193.The system of claim 189, further comprising: a human interface providingat least one output.
 194. A tissue penetrating system, comprising: aplurality of cartridges, each cartridge including an analyte detectingmember coupled to a sample chamber, the analyte detecting member beingconfigured to determine a concentration of an analyte in a body fluidusing a sample of less than 1 μL of a body fluid disposed in the samplechamber; and each of the cartridges having a plurality of sealspositioned so that the sample chamber remains in a sterile environmentbefore launch of a penetrating member, the plurality of modules coupledtogether in an array.
 195. A method of penetrating a target tissue,comprising: providing a tissue penetrating system with a penetratingmember and an analyte detecting member coupled to a sample chamber;advancing a penetrating member through the target tissue; withdrawingthe penetrating member from the target tissue; receiving no more than 1μL of a body fluid in the sample chamber.
 196. A body fluid samplingsystem for use on a tissue site, the system comprising: a drive forcegenerator; a penetrating member operatively coupled to said forcegenerator, said force generator moving said member along a path out of ahousing having a penetrating member exit, into said tissue site,stopping in said tissue site, and withdrawing out of said tissue site;wherein said penetrating member is an elongate member without a moldedattachment; a coupler on said force generator configured to engage atleast a portion of said elongate portion of the penetrating member anddrive said member along a path into a tissue site and withdrawn from atissue site; an analyte detecting member positioned to receive fluidfrom a wound created by said penetrating member, said detection memberconfigured to determine a concentration of an analyte in the fluid usinga sample of less than 1 mL of the fluid; and a user interface configuredto relay at least one of, penetrating member performance or apenetrating member setting.
 197. A body fluid sampling system for use ona tissue site, the system comprising: a drive force generator; apenetrating member operatively coupled to said force generator, saidforce generator moving said member along a path out of a housing havinga penetrating member exit, into said tissue site, stopping in saidtissue site, and withdrawing out of said tissue site; wherein saidpenetrating member is an elongate member without a molded attachment; acoupler on said force generator configured to engage at least a portionof said elongate portion of the penetrating member and drive said memberalong a path into a tissue site and withdrawn from a tissue site; ananalyte detecting member positioned to receive fluid from a woundcreated by said penetrating member, said detection member configured todetermine a concentration of an analyte in the fluid using a sample ofless than 1 mL of the fluid; and a human interface providing at leastone output.
 198. A body fluid sampling system for use on a tissue site,the system comprising: a drive force generator; a plurality ofcartridges each containing a penetrating member, each of said cartridgescoupled together to define a flexible array; a transport device formoving each of said cartridges into a launch position operativelycoupling said penetrating member to the force generator; an analytedetecting member positioned to receive fluid from a wound created bysaid penetrating member, said detection member configured to determine aconcentration of an analyte in the fluid using a sample of less than 1mL of the fluid; and a user interface configured to relay at least oneof, penetrating member performance or a penetrating member setting. 199.A body fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a plurality of cartridges eachcontaining a penetrating member, each of said cartridges coupledtogether to define a flexible array; a transport device for moving eachof said cartridges into a launch position operatively coupling saidpenetrating member to the force generator; an analyte detecting memberpositioned to receive fluid from a wound created by said penetratingmember, said detection member configured to determine a concentration ofan analyte in the fluid using a sample of less than 1 mL of the fluid;and a human interface providing at least one output.
 200. A body fluidsampling system for use on a tissue site, the system comprising: a driveforce generator; a penetrating member having an elongate portion withouta molded attachment and operatively coupled to said force generator; asterility enclosure covering at least a tip of said penetrating member,said sterility enclosure removed from said penetrating member prior toactuation of the member and positioned so that the penetrating memberwill not contact said enclosure during actuation; an analyte detectingmember positioned to receive fluid from a wound created by saidpenetrating member, said detection member configured to determine aconcentration of an analyte in the fluid using a sample of less than 1mL of the fluid; and a user interface configured to relay at least oneof, penetrating member performance or a penetrating member setting. 201.A body fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a penetrating member having anelongate portion without a molded attachment and operatively coupled tosaid force generator; a sterility enclosure covering at least a tip ofsaid penetrating member, said sterility enclosure removed from saidpenetrating member prior to actuation of the member and positioned sothat the penetrating member will not contact said enclosure duringactuation; an analyte detecting member positioned to receive fluid froma wound created by said penetrating member, said detection memberconfigured to determine a concentration of an analyte in the fluid usinga sample of less than 1 mL of the fluid; and a human interface providingat least one output.
 202. A body fluid sampling system for use on atissue site, the system comprising: a drive force generator; apenetrating member having an elongate portion without a moldedattachment and operatively coupled to said force generator; a sterilityenclosure creating a sterile environment around at least a tip of saidpenetrating member, said penetrating member breaching said sterileenvironment during actuation; an analyte detecting member positioned toreceive fluid from a wound created by said penetrating member, saiddetection member configured to determine a concentration of an analytein the fluid using a sample of less than 1 mL of the fluid; and a userinterface configured to relay at least one of, penetrating memberperformance or a penetrating member setting.
 203. A body fluid samplingsystem for use on a tissue site, the system comprising: a drive forcegenerator; a penetrating member having an elongate portion without amolded attachment and operatively coupled to said force generator; asterility enclosure creating a sterile environment around at least a tipof said penetrating member, said penetrating member breaching saidsterile environment during actuation; an analyte detecting memberpositioned to receive fluid from a wound created by said penetratingmember, said detection member configured to determine a concentration ofan analyte in the fluid using a sample of less than 1 mL of the fluid;and a human interface providing at least one output.
 204. A body fluidsampling system for use on a tissue site, the system comprising: a driveforce generator; a penetrating member operatively coupled to said forcegenerator, said force generator moving said member along a path out of ahousing having said a penetrating member exit, into said tissue site,stopping in said tissue site, and withdrawing out of said tissue site; askin stabilizer device suitable for stretching a surface of a tissuesite, said skin stabilizer at least partially surrounding thepenetrating member exit; an analyte detecting member positioned toreceive fluid from a wound created by said penetrating member, saiddetection member configured to determine a concentration of an analytein the fluid using a sample of less than 1 mL of the fluid; and a userinterface configured to relay at least one of, penetrating memberperformance or a penetrating member setting.
 205. A body fluid samplingsystem for use on a tissue site, the system comprising: a drive forcegenerator; a penetrating member operatively coupled to said forcegenerator, said force generator moving said member along a path out of ahousing having said a penetrating member exit, into said tissue site,stopping in said tissue site, and withdrawing out of said tissue site; askin stabilizer device suitable for stretching a surface of a tissuesite, said skin stabilizer at least partially surrounding thepenetrating member exit; an analyte detecting member positioned toreceive fluid from a wound created by said penetrating member, saiddetection member configured to determine a concentration of an analytein the fluid using a sample of less than 1 mL of the fluid; and a humaninterface providing at least one output.
 206. A body fluid samplingsystem for use on a tissue site, the system comprising: a drive forcegenerator; a penetrating member operatively coupled to said forcegenerator, said force generator moving said member along a path out of ahousing having said a penetrating member exit, into said tissue site,stopping in said tissue site, and withdrawing out of said tissue site;an analyte detecting member positioned to receive fluid from a woundcreated by said penetrating member, said detection member configured todetermine a concentration of an analyte in the fluid using a sample ofless than 1 mL of the fluid; and a user interface configured to relay atleast one of, penetrating member performance or a penetrating membersetting.
 207. A body fluid sampling system for use on a tissue site, thesystem comprising: a drive force generator; a penetrating memberoperatively coupled to said force generator, said force generator movingsaid member along a path out of a housing having said a penetratingmember exit, into said tissue site, stopping in said tissue site, andwithdrawing out of said tissue site; an analyte detecting memberpositioned to receive fluid from a wound created by said penetratingmember, said detection member configured to determine a concentration ofan analyte in the fluid using a sample of less than 1 mL of the fluid;and a human interface providing at least one output.
 208. A device foruse with penetrating member driver to penetrate tissue, the devicecomprising: a single cartridge having a plurality of openings; aplurality of penetrating members having a sharpened tips movable topenetrate tissue; a plurality of analyte sensors coupled to said singlecartridge; and a sterility barrier covering said openings.
 209. Thedevice of claim 208 wherein said analyte sensors are positioned on thecartridge to receive body fluid from a wound in the tissue created by apenetrating member.
 210. The device of claim 208 wherein said analytesensors are electrochemical sensors.
 211. The device of claim 208wherein said analyte sensor are potentiometric sensors.
 212. The deviceof claim 208 wherein said analyte sensors are configured to determineanalyte levels using a body fluid sample of less than about 1 microliter.
 213. The device of claim 208 wherein said sterility barrier,prior to being breached, maintains a sterile environment inside saidopenings.
 214. A device for use with a penetrating member driver topenetrate tissue, the device comprising: a single cartridge having aplurality of cavities; a plurality of penetrating members coupled tosaid single cartridge and couplable to the penetrating member driver,said penetrating members movable to extend outward to penetrate tissue;a plurality of analyte sensors coupled to said single cartridge, saidsensors receiving body fluid entering said cavities.
 215. The device ofclaim 214 wherein said sensors define a portion of said cavities. 216.The device of claim 214 wherein said sensors are mounted in saidcavities.
 217. The device of claim 214 further comprising a sterilitybarrier covering said cavities.
 218. The device of claim 214 whereinsaid analyte sensors are electrochemical sensors.
 219. The device ofclaim 214 wherein said analyte sensor are potentiometric sensors. 220.The device of claim 214 wherein said analyte sensors are configured todetermine analyte levels using a body fluid sample of less than about 1microliter.
 221. The device of claim 214 wherein at least some of saidanalyte sensors are positioned on a bottom surface of said cavities.222. The device of claim 214 wherein at least some of said analytesensors are positioned on a side surface of said cavities.
 223. Thedevice of claim 214 wherein at least some of said analyte sensors arepositioned on a top surface of said cavities.
 224. The device of claim214 wherein at least some of said analyte sensors are positioned on acurved surface of said cavities.
 225. A method comprising: providing acartridge having a plurality of penetrating members and a plurality ofanalyte sensors; using a penetrating member driver to actuate saidpenetrating members to penetrate tissue and wherein used penetratingmembers and sensors remain coupled to said cartridge; wherein saidcartridge containing said used penetrating members and used sensors, isdisposable; and replacing the entire cartridge by inserting a newcartridge having penetrating members and sensors into the penetratingmember driver.
 226. A lancing system for use with a penetrating memberdriver, said system comprising: means for housing a plurality ofpenetrating members and analyte sensors; means for releasing one of saidpenetrating member from a sealed enclosure on said housing means; meansfor operatively coupling one of said penetrating member to saidpenetrating member driver; and wherein one of said analyte sensorsreceives body fluid from a wound created in said tissue by one of saidpenetrating members.
 227. A method for determining a concentration of ananalyte in body fluid, comprising: collecting a sample of body fluid ofabout 500 nL or less; filling a measurement zone of an electrochemicalsensor with at least a portion of the sample; and determining theconcentration of the analyte in the sample using a potentiometrictechnique.
 228. A method comprising: creating an unassisted flow of abody fluid from the patient; transporting a portion of the body fluidinto an analyte sensor configured and arranged to determine theconcentration of the analyte from 500 nL or less of body fluid; anddetermining the concentration of the analyte in the body fluid from theportion of the body fluid transported into the analyte sensor.
 229. Adevice for use with a penetrating member driver to penetrate tissue, thedevice comprising: a single cartridge having a plurality of openings; aplurality of penetrating members having a sharpened tips movable topenetrate tissue; a plurality of optical analyte sensors coupled to saidsingle cartridge; and a sterility barrier covering said openings. 230.The device of claim 229 wherein cartridge includes a plurality oftransparent windows aligned with said optical analyte sensors.
 231. Thedevice of claim 229 wherein said optical analyte sensors are positionedon the cartridge to receive body fluid from a wound in the tissuecreated by a penetrating member.
 232. The device of claim 229 whereinsaid optical analyte sensors are configured to determine analyte levelsusing a body fluid sample of less than about 1 microliter.
 233. Thedevice of claim 229 wherein said sterility barrier, prior to beingbreached, maintains a sterile environment inside said openings.
 234. Adevice for use with a penetrating member driver to penetrate tissue, thedevice comprising: a single cartridge having a plurality of cavities; aplurality of penetrating members coupled to said single cartridge andcouplable to the penetrating member driver, said penetrating membersmovable to extend outward to penetrate tissue; and a plurality ofoptical analyte sensors coupled to said single cartridge, said sensorsreceiving body fluid entering said cavities.
 235. The device of claim234 wherein cartridge includes a plurality of transparent windowsaligned with said optical analyte sensors.
 236. The device of claim 234wherein said sensors define a portion of said cavities.
 237. The deviceof claim 234 wherein said sensors are mounted in said cavities.
 238. Thedevice of claim 234 further comprising a sterility barrier covering saidcavities.
 239. The device of claim 234 wherein said optical analytesensors are configured to determine analyte levels using a body fluidsample of less than about 1 microliter.
 240. The device of claim 234wherein at least some of said optical analyte sensors are positioned ona bottom surface of said cavities.
 241. The device of claim 234 whereinat least some of said optical analyte sensors are positioned on a sidesurface of said cavities.
 242. The device of claim 234 wherein at leastsome of said optical analyte sensors are positioned on a top surface ofsaid cavities.
 243. The device of claim 234 wherein at least some ofsaid optical analyte sensors are positioned on a curved surface of saidcavities.
 244. A method comprising: providing a cartridge having aplurality of penetrating members and a plurality of optical analytesensors; using a penetrating member driver to actuate said penetratingmembers to penetrate tissue and wherein used penetrating members andsensors remain coupled to said cartridge; wherein said cartridgecontaining said used penetrating members and used sensors, isdisposable; and replacing the entire cartridge by inserting a newcartridge having penetrating members and sensors into the penetratingmember driver.
 245. A lancing system for use with a penetrating memberdriver, said system comprising: means for housing a plurality ofpenetrating members and optical analyte sensors; means for releasing oneof said penetrating member from a sealed enclosure on said housingmeans; means for operatively coupling one of said penetrating member tosaid penetrating member driver; and wherein one of said optical analytesensors receives body fluid from a wound created in said tissue by oneof said penetrating members.
 246. A body fluid sampling system for useon a tissue site, the system comprising: a single drive force generator;a plurality of penetrating members operatively coupled to said forcegenerator, said force generator moving each of said members along a pathout of a housing having a penetrating member exit, into said tissuesite, stopping in said tissue site, and withdrawing out of said tissuesite; and a flexible support member coupling said penetrating members todefine a linear array, said support member being movable and configuredto move each of said penetrating members to a launch position associatedwith said force generator.
 247. The system of claim 246 furthercomprising an analyte detecting member.
 248. The system of claim 246further comprising a plurality of analyte detecting members positionedto receive body fluid.
 249. The system of claim 246, further comprising:a sample chamber with an opening for transport of a body fluid into thesample chamber, the sample chamber being sized to receive no more than1.0 mL of the body fluid.
 250. The system of claim 246, furthercomprising: an analyte detecting member coupled to a sample chamber, theanalyte detecting member being configured to determine a concentrationof an analyte in a body fluid using a sample that does not exceed avolume of 1 mL of a body fluid disposed in the sample chamber.
 251. Abody fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a plurality of penetrating membersoperatively coupled to said force generator, said force generator movingeach of said members along a path out of a housing having a penetratingmember exit, into said tissue site, stopping in said tissue site, andwithdrawing out of said tissue site; a flexible support member couplingsaid penetrating members to define a linear array, said support memberbeing movable and configured to move each of said penetrating members toa launch position associated with said force generator; and an analytedetection member positioned to receive fluid from a wound created bysaid penetrating member, said detection member configured to determine aconcentration of an analyte in the fluid using a sample of less than 1mL of the fluid.
 252. A tissue penetration device, comprising: apenetrating member driver; a cartridge; a plurality of penetratingmembers integrated with the cartridge, each of a penetrating membercoupled to the penetrating member driver when advanced along a path intoa tissue target; and a user interface configured to relay at least oneof, skin penetrating performance or a skin penetrating setting.
 253. Thesystem of claim 252, further comprising: a data interface configured tocouple the tissue penetrating system to at least one of, supportequipment with a data interface and the internet.
 254. The system ofclaim 252, wherein the support equipment is selected from at least oneof, a base station, home computer, central server, and main processingequipment for storing glucose level information.
 255. A tissuepenetrating device, comprising: a housing; a penetrating member driver;a cartridge; a plurality of penetrating members integrated with thecartridge, each of a penetrating member being coupled to the penetratingmember driver when advanced along a path into a tissue target; and ahuman interface providing at least one output.
 256. The system of claim255, wherein the at least one output is selected from, a penetrationevent of a penetrating member, number of penetrating members remaining,time of day, alarm, penetrating member trajectory waveform profileinformation, force for last penetration event, the last penetrationevent, how or low battery status, analyte status, time to changecassette status, jamming malfunction, and system status.
 257. The systemof claim 255, wherein the housing is selected from at least one of, atelephone, a watch, a PDA, electronic device, medical device, point ofcare device and a decentralized diagnostic device.
 258. The system ofclaim 255, further comprising: an input device coupled to the housing,the input device selected from one or more pushbuttons, a touch padindependent of the display device, or a touch sensitive screen on avisual display.
 259. The system of claim 255, further comprising: a dataexchange device for coupling the tissue penetrating system to supportequipment.
 260. The system of claim 259, further comprising: a datainterface configured to couple the tissue penetrating system to supportequipment with a data interface.
 261. A tissue penetrating system,comprising: a plurality of penetrating members; a penetrating memberdriver coupled to the plurality of penetrating members; a cartridgetransport device; a plurality of cartridges each associated with apenetrating member, the cartridge transport device being configured tomove each cartridge to a position aligning a penetrating member with thepenetrating member driver to drive the penetrating member along a pathinto a target tissue site; and a user interface configured to relay atleast one of, skin penetrating performance or a skin penetratingsetting.
 262. The system of claim 261, further comprising: a datainterface configured to couple the tissue penetrating system to at leastone of, support equipment with a data interface and the internet.
 263. Abody fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a penetrating member operativelycoupled to said force generator, said force generator moving said memberalong a path out of a housing having a penetrating member exit, intosaid tissue site, stopping in said tissue site, and withdrawing out ofsaid tissue site; wherein said penetrating member is an elongate memberwithout a molded attachment; a coupler on said force generatorconfigured to engage at least a portion of said elongate portion of thepenetrating member and drive said member along a path into a tissue siteand withdrawn from a tissue site; and an analyte detecting memberpositioned to receive fluid from a wound created by said penetratingmember, said detection member configured to determine a concentration ofan analyte in the fluid using a sample of less than 1 mL of the fluid.264. A body fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a plurality of cartridges eachcontaining a penetrating member, each of said cartridges coupledtogether to define a flexible array; a transport device for moving eachof said cartridges into a launch position operatively coupling saidpenetrating member to the force generator; and an analyte detectingmember positioned to receive fluid from a wound created by saidpenetrating member, said detection member configured to determine aconcentration of an analyte in the fluid using a sample of less than 1mL of the fluid.
 265. A body fluid sampling system for use on a tissuesite, the system comprising: a drive force generator; a penetratingmember having an elongate portion without a molded attachment andoperatively coupled to said force generator; a sterility enclosurecovering at least a tip of said penetrating member, said sterilityenclosure removed from said penetrating member prior to actuation of themember and positioned so that the penetrating member will not contactsaid enclosure during actuation; and an analyte detecting memberpositioned to receive fluid from a wound created by said penetratingmember, said detection member configured to determine a concentration ofan analyte in the fluid using a sample of less than 1 mL of the fluid.266. A body fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a penetrating member having anelongate portion without a molded attachment and operatively coupled tosaid force generator; a sterility enclosure creating a sterileenvironment around at least a tip of said penetrating member, saidpenetrating member breaching said sterile environment during actuation;and an analyte detecting member positioned to receive fluid from a woundcreated by said penetrating member, said detection member configured todetermine a concentration of an analyte in the fluid using a sample ofless than 1 mL of the fluid.
 267. A tissue penetrating system,comprising: a plurality of penetrating members each with a tip; apenetrating member driver coupled to the plurality of penetratingmembers; each tip of a penetrating member being uncovered during launchof the penetrating member by the penetrating member driver; and asupport with a plurality of openings, each of an opening receiving apenetrating member.
 268. The system of claim 267, further comprising: aplurality of cartridges integrated in a cassette.
 269. The system ofclaim 268, wherein each cartridge has an exit port, and upon launch eachpenetrating member exists from the exit port.
 270. The system of claim267, further comprising: an analyte detecting member.
 271. The system ofclaim 267, further comprising: a plurality of analyte detecting memberseach coupled to a penetrating member.
 272. The system of claim 267,further comprising: a sample chamber with an opening for transport of abody fluid into the sample chamber, the sample chamber being sized toreceive no more than 1.0 μL of the body fluid.
 273. The system of claim267, further comprising: an analyte detecting member coupled to a samplechamber, the analyte detecting member being configured to determine aconcentration of an analyte in a body fluid using a sample that does notexceed a volume of 1 μL of a body fluid disposed in the sample chamber.274. The system of claim 267, further comprising: a tissue stabilizerdevice coupled to the housing.
 275. The system of claim 274, wherein thetissue stabilizer device is configured to enhance fluid flow from atarget tissue.
 276. The system of claim 274, wherein the tissuestabilizer device creates a stretching of a skin surface.
 277. Thesystem of claim 274, wherein the tissue stabilizer device is configuredto apply a force to a target tissue and cause the target tissue to pressin an inward direction relative to the housing member.
 278. The systemof claim 274, wherein the tissue stabilizing member applies astimulation to a target tissue.
 279. The system of claim 267, furthercomprising: a seal formed by a fracturable material between thepenetrating member and a cartridge, the seal being positioned at leastone of a distal port or a proximal port of the cartridge.
 280. Thesystem of claim 274, further comprising: a second fracturable seallocated at least one of the distal port or proximal port of thecartridge.
 281. The system of claim 267, wherein each penetrating membereach penetrating members is an elongate member without moldedattachments.
 282. The system of claim 267, further comprising: apenetrating member transport device for moving each of a penetratingmember into a position aligned with the penetrating member driver. 283.The system of claim 267, further comprising: a belt for holding thepenetrating members in an array configuration.
 284. The system of claim267, further comprising: a tape device configured to hold thepenetrating members in an array configuration.
 285. The system of claim267, further comprising: a support channel configured to hold thepenetrating members in an array configuration.
 286. The system of claim267, further comprising: a cog configured to hold the penetratingmembers in an array configuration.
 287. The system of claim 267, furthercomprising: a plurality of connectors between penetrating members forholding the penetrating members in an array configuration.
 288. Thesystem of claim 267, wherein the support is a bandolier.
 289. The systemof claim 267, wherein the support is a drum.
 290. A tissue penetrationdevice, comprising: a penetrating member driver; a cartridge; aplurality of penetrating members integrated with the cartridge, each ofa penetrating member coupled to the penetrating member driver whenadvanced along a path into a tissue target; and a support with aplurality of openings, each opening receiving a penetrating member, eachtip of a penetrating member being uncovered during launch of apenetrating member by the penetrating driver member.
 291. The system ofclaim 290, further comprising: an analyte detecting member.
 292. Thesystem of claim 290, further comprising: a plurality of analytedetecting members each coupled to a penetrating member.
 293. The systemof claim 290, further comprising: a sample chamber with an opening fortransport of a body fluid into the sample chamber, the sample chamberbeing sized to receive no more than 1.0 μL of the body fluid.
 294. Thesystem of claim 290, further comprising: an analyte detecting membercoupled to a sample chamber, the analyte detecting member beingconfigured to determine a concentration of an analyte in a body fluidusing a sample that does not exceed a volume of 1 μL of a body fluiddisposed in the sample chamber.
 295. The system of claim 290, furthercomprising: a tissue stabilizer device coupled to the housing.
 296. Thesystem of claim 295, wherein the tissue stabilizer device is configuredto enhance fluid flow from a target tissue.
 297. The system of claim296, wherein the tissue stabilizer device creates a stretching of a skinsurface.
 298. The system of claim 296, wherein the tissue stabilizerdevice is configured to apply a force to a target tissue and cause thetarget tissue to press in an inward direction relative to the housingmember.
 299. The system of claim 296, wherein the tissue stabilizingmember applies a stimulation to a target tissue.
 300. The system ofclaim 290, further comprising: a seal formed by a fracturable materialbetween the penetrating member and the cartridge, the seal beingpositioned at least one of a distal port or a proximal port of thecartridge.
 301. The system of claim 296, further comprising: a secondfracturable seal located at least one of the distal port or proximalport of the cartridge.
 302. The system of claim 267, wherein eachpenetrating member each penetrating members is an elongate memberwithout molded attachments.
 303. The system of claim 267, furthercomprising: a penetrating member transport device for moving each of apenetrating member into a position aligned with the penetrating memberdriver.
 304. The system of claim 290, further comprising: a belt forholding the penetrating members in an array configuration.
 305. Thesystem of claim 290, further comprising: a tape device configured tohold the penetrating members in an array configuration.
 306. The systemof claim 290, further comprising: a support channel configured to holdthe penetrating members in an array configuration.
 307. The system ofclaim 290, further comprising: a cog configured to hold the penetratingmembers in an array configuration.
 308. The system of claim 290, furthercomprising: a plurality of connectors between penetrating members forholding the penetrating members in an array configuration.
 309. Thesystem of claim 290, wherein the support is a bandolier.
 310. The systemof claim 290, wherein the support is a drum.
 311. A tissue penetratingsystem, comprising: a plurality of penetrating members each having atleast a penetrating member tip in its own sterile enclosure; apenetrating member driver; and a penetrating member transport fortransporting a penetrating member from a storage area to the penetratingmember driver.
 312. The system of claim 311, wherein the storage area isa plurality of cartridges.
 313. The system of claim 312, wherein eachpenetrating member is associated with a cartridge.
 314. A tissuepenetrating system, comprising: a plurality of penetrating members, eachpenetrating member having a penetrating member tip in its own sterileenclosure; a penetrating member driver; and a penetrating membertransport for transporting penetrating members from a storage area tothe penetrating member driver.
 315. The system of claim 314, furthercomprising: an analyte detecting member.
 316. The system of claim 314,further comprising: a plurality of analyte detecting members eachcoupled to a penetrating member.
 317. The system of claim 314, furthercomprising: a sample chamber with an opening for transport of a bodyfluid into the sample chamber, the sample chamber being sized to receiveno more than 1.0 μL of the body fluid.
 318. The system of claim 314,further comprising: an analyte detecting member coupled to a samplechamber, the analyte detecting member being configured to determine aconcentration of an analyte in a body fluid using a sample that does notexceed a volume of 1 μL of a body fluid disposed in the sample chamber.319. The system of claim 314, further comprising: a tissue stabilizerdevice coupled to the housing.
 320. The system of claim 319, wherein thetissue stabilizer device is configured to enhance fluid flow from atarget tissue.
 321. The system of claim 319, wherein the tissuestabilizer device creates a stretching of a skin surface.
 322. Thesystem of claim 319, wherein the tissue stabilizer device is configuredto apply a force to a target tissue and cause the target tissue to pressin an inward direction relative to the housing member.
 323. The systemof claim 319, wherein the tissue stabilizing member applies astimulation to a target tissue.
 324. The system of claim 314, furthercomprising: a seal formed by a fracturable material between thepenetrating member and a cartridge, the seal being positioned at leastone of a distal port or a proximal port of the cartridge.
 325. Thesystem of claim 319, further comprising a second fracturable seallocated at least one of the distal port or proximal port of thecartridge.
 326. The system of claim 314, wherein each penetrating membereach penetrating member is an elongated member without moldedattachments.
 327. The system of claim 314, further comprising: apenetrating member transport device for moving each of a penetratingmember into a position aligned with the penetrating member driver. 328.The system of claim 314, further comprising: a belt for holding thepenetrating members in an array configuration.
 329. The system of claim314, further comprising: a tape device configured to hold thepenetrating members in an array configuration.
 330. The system of claim314, further comprising: a support channel configured to hold thepenetrating members in an array configuration.
 331. The system of claim314, further comprising: a cog configured to hold the penetratingmembers in an array configuration.
 332. The system of claim 314, furthercomprising: a plurality of connectors between penetrating members forholding the penetrating members in an array configuration.
 333. Thesystem of claim 314, wherein the support is a bandolier.
 334. The systemof claim 314, wherein the support is a drum.
 335. A tissue penetratingsystem, comprising: a plurality of penetrating members; a flexible tapecoupling the plurality of penetrating members into a flexible array; apenetrating member driver coupled to the plurality of penetratingmembers configured to drive and withdraw a penetrating member into andout of a target tissue; and a transport device for sequentially couplingeach of a penetrating member to the penetrating member driver.
 336. Abody fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a penetrating member having anelongate portion without a molded attachment and operatively coupled tosaid force generator; a sterility enclosure covering at least a tip ofsaid penetrating member, said sterility enclosure removed from saidpenetrating member prior to actuation of the member and positioned sothat the penetrating member will not contact said enclosure duringactuation; a skin stabilizing member associated with said housing andpositioned to at least partially surround an impact location of thepenetrating member on the tissue site; and a user interface configuredto relay at least one of, penetrating member performance or apenetrating member setting.
 337. A body fluid sampling system for use ona tissue site, the system comprising: a drive force generator; apenetrating member having an elongate portion without a moldedattachment and operatively coupled to said force generator; a sterilityenclosure covering at least a tip of said penetrating member, saidsterility enclosure removed from said penetrating member prior toactuation of the member and positioned so that the penetrating memberwill not contact said enclosure during actuation; a skin stabilizingmember associated with said housing and positioned to at least partiallysurround an impact location of the penetrating member on the tissuesite; and a human interface providing at least one output.
 338. A bodyfluid sampling system for use on a tissue site, the system comprising: adrive force generator; a penetrating member having an elongate portionwithout a molded attachment and operatively coupled to said forcegenerator; a sterility enclosure creating a sterile environment aroundat least a tip of said penetrating member, said penetrating memberbreaching said sterile environment during actuation; a skin stabilizingmember associated with said housing and positioned to at least partiallysurround an impact location of the penetrating member on the tissuesite; and a user interface configured to relay at least one of,penetrating member performance or a penetrating member setting.
 339. Abody fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a penetrating member having anelongate portion without a molded attachment and operatively coupled tosaid force generator; a sterility enclosure creating a sterileenvironment around at least a tip of said penetrating member, saidpenetrating member breaching said sterile environment during actuation;a skin stabilizing member associated with said housing and positioned toat least partially surround an impact location of the penetrating memberon the tissue site; and a human interface providing at least one output.340. A tissue penetrating system, comprising: a plurality of cartridgeseach with a distal port and a proximal port; a plurality of penetratingmembers each coupled to a cartridge, each penetrating member having asharpened distal tip and a shaft portion slidably disposed within thecartridge; and a seal formed by a fracturable material between thepenetrating member and the cartridge, the seal being positioned at leastone of a distal port or a proximal port of the cartridge.
 341. Thesystem of claim 340, further comprising: a plurality of cartridgesintegrated in a cassette.
 342. The system of claim 341, wherein eachcartridge has an exit port, and upon launch each penetrating memberexists from the exit port.
 343. The system of claim 340, furthercomprising: an analyte detecting member.
 344. The system of claim 340,further comprising: a plurality of analyte detecting members eachcoupled to a penetrating member.
 345. The system of claim 340, furthercomprising: a sample chamber with an opening for transport of a bodyfluid into the sample chamber, the sample chamber being sized to receiveno more than 1.0 μL of the body fluid.
 346. The system of claim 340,further comprising: an analyte detecting member coupled to a samplechamber, the analyte detecting member being configured to determine aconcentration of an analyte in a body fluid using a sample that does notexceed a volume of 1 μL of a body fluid disposed in the sample chamber.347. The system of claim 340, further comprising: a tissue stabilizerdevice coupled to the housing.
 348. The system of claim 347, wherein thetissue stabilizer device is configured to enhance fluid flow from atarget tissue.
 349. The system of claim 347, wherein the tissuestabilizer device creates a stretching of a skin surface.
 350. Thesystem of claim 347, wherein the tissue stabilizer device is configuredto apply a force to a target tissue and cause the target tissue to pressin an inward direction relative to the housing member.
 351. The systemof claim 347, wherein the tissue stabilizing member applies astimulation to a target tissue.
 352. The system of claim 340, whereineach penetrating member each penetrating members is an elongate memberwithout molded attachments.
 353. The system of claim 340, furthercomprising: a penetrating member transport device for moving each of apenetrating member into a position aligned with the penetrating memberdriver.
 354. The system of claim 340, further comprising: a belt forholding the penetrating members in an array configuration.
 355. Thesystem of claim 340, further comprising: a tape device configured tohold the penetrating members in an array configuration.
 356. The systemof claim 340, further comprising: a support channel configured to holdthe penetrating members in an array configuration.
 357. The system ofclaim 340, further comprising: a cog configured to hold the penetratingmembers in an array configuration.
 358. The system of claim 340, furthercomprising: a plurality of connectors between penetrating members forholding the penetrating members in an array configuration.
 359. Thesystem of claim 340, further comprising: a support structure forreceiving the penetrating members.
 360. The system of claim 359, whereinthe support structure is a bandolier.
 361. The system of claim 359,wherein the support structure is a drum.
 362. A tissue penetratingsystem, comprising: a cartridge with a distal port and a proximal port;a sample chamber; a plurality of penetrating members each with asharpened distal tip and a shaft portion slidably disposed within thecartridge; and a first seal formed at the distal port and a second sealformed at the proximal port, wherein prior to lancing the first seal andsecond seal maintain the distal tip of a penetrating member and thesample chamber in a sterile environment.
 363. A tissue penetratingsystem, comprising: a cartridge with a distal port and a proximal port;a plurality of sample chambers; a plurality of penetrating members eachwith a sharpened distal tip and a shaft portion slidably disposed withinthe cartridge, each penetrating member being associated with a samplechamber; and a first seal formed at the distal port and a second sealformed at the proximal port, wherein prior to lancing the first seal andsecond seal maintain the distal tip of a penetrating member and thesample chamber in a sterile environment.
 364. The system of claim 363,further comprising: a plurality of cartridges integrated in a cassette.365. The system of claim 364, wherein each cartridge has an exit port,and upon launch each penetrating member exists from the exit port. 366.The system of claim 363, further comprising: a plurality of analytedetecting members each coupled to a penetrating member.
 367. The systemof claim 363, wherein each sample chamber is sized to receive no morethan 1.0 μL of the body fluid.
 368. The system of claim 363, furthercomprising: an analyte detecting member coupled to each sample chamber,the analyte detecting member being configured to determine aconcentration of an analyte in a body fluid using a sample that does notexceed a volume of 1 μL of a body fluid disposed in the sample chamber.369. The system of claim 363, further comprising: a tissue stabilizerdevice coupled to the housing.
 370. The system of claim 369, wherein thetissue stabilizer device is configured to enhance fluid flow from atarget tissue.
 371. The system of claim 369, wherein the tissuestabilizer device creates a stretching of a skin surface.
 372. Thesystem of claim 369, wherein the tissue stabilizer device is configuredto apply a force to a target tissue and cause the target tissue to pressin an inward direction relative to the housing member.
 373. The systemof claim 369, wherein the tissue stabilizing member applies astimulation to a target tissue.
 374. The system of claim 363, whereineach penetrating member each penetrating member is an elongated memberwithout molded attachments.
 375. The system of claim 363, furthercomprising: a penetrating member transport device for moving each of apenetrating member into a position aligned with the penetrating memberdriver.
 376. The system of claim 363, further comprising: a belt forholding the penetrating members in an array configuration.
 377. Thesystem of claim 363, further comprising: a tape device configured tohold the penetrating members in an array configuration.
 378. The systemof claim 363, further comprising: a support channel configured to holdthe penetrating members in an array configuration.
 379. The system ofclaim 363, further comprising: a cog configured to hold the penetratingmembers in an array configuration.
 380. The system of claim 363, furthercomprising: a plurality of connectors between penetrating members forholding the penetrating members in an array configuration.
 381. Thesystem of claim 363, further comprising: a support structure forreceiving the penetrating members.
 382. The system of claim 381, whereinthe support structure is a bandolier.
 383. The system of claim 381,wherein the support structure is a drum.
 384. A tissue penetratingsystem, comprising: a cartridge having a distal port and a proximalport; a plurality of penetrating members; a plurality of lumens betweenthe distal port and the proximal port for slidably receiving apenetrating member; a sample chamber defined by the cartridge having anopening; a first seal covering the distal port; and a second sealcovering the proximal port.
 385. The system of claim 384, furthercomprising: a plurality of sample chambers each associated with apenetrating member.
 386. The system of claim 385, wherein the pluralityof cartridges is arranged as a bandolier.
 387. The system of claim 385,wherein the array is a stack.
 388. The system of claim 387, wherein theplurality of cartridges is arranged as a bandolier.
 389. The system ofclaim 387, wherein each of the cartridges has one of the seals locatedat a proximal port and another of the seals located at a distal port.390. The system of claim 387, further comprising: a belt for holding thecartridges in the array.
 391. The system of claim 387, furthercomprising: a tape for holding the cartridges in the array.
 392. Thesystem of claim 387, further comprising: a support channel for holdingthe cartridges in the array.
 393. The system of claim 387, furthercomprising: a cog for holding the cartridges in the array.
 394. A tissuepenetrating system, comprising: a plurality of penetrating members eachhaving a sharpened distal tip; a penetrating member driver; and aplurality of cartridges coupled in an array and each housing apenetrating member, each cartridge configured to permit the penetratingmember driver to engage each of the penetrating members sequentially,each cartridge having a plurality of seals positioned to provide thatthe sharpened distal tip remains in a sterile environment beforepenetrating a target site, each penetrating being launched withoutbreaking a seal.
 395. A tissue penetrating system, comprising: aplurality of cartridges each with a distal port and a proximal port; aplurality of penetrating members each associated with a cartridge, eachpenetrating member having a sharpened distal tip and a shaft portionslidably disposed within the cartridge; a seal formed by a fracturablematerial between the penetrating member and each cartridge, the sealbeing positioned at least one of a distal port or a proximal port of thecartridge; and a cartridge transport device for moving each of thecartridges to a position that aligns the penetrating member with thepenetrating member driver so that the penetrating member can be drivenalong a path into a target tissue.
 396. A method of penetrating a tissuesite, comprising: providing a tissue penetrating system that includes acartridge, a sample chamber, a penetrating member and at least one sealthat maintains the penetrating member in a sterile condition prior tolaunch of the penetrating member; fracturing at least a portion of theseal prior to launch of the penetrating member; launching thepenetrating member to a target tissue; and receiving a body fluid in thesample chamber of the tissue penetrating system.
 397. The method ofclaim 396, wherein no more than 1 μL of the body fluid is received inthe sample chamber.
 398. A tissue penetrating system, comprising: acartridge with a distal port and a proximal port; a plurality ofpenetrating members each with a sharpened distal tip and a shaft portionslidably disposed within the cartridge; and a seal formed by afracturable material between the penetrating member and the cartridge,the seal being positioned at least one of a distal port or a proximalport of the cartridge.
 399. A tissue penetrating system, comprising: ahousing member; a plurality of penetrating members positioned in thehousing member, and a pressure applicator coupled to the housing member.400. The system of claim 399, wherein the pressure applicator isconfigured to enhance fluid flow from a target tissue.
 401. The systemof claim 399, wherein the tissue stabilizer member creates a stretchingof a skin surface.
 402. The system of claim 399, wherein the pressureapplicator is configured to apply a force to a target tissue and causethe target tissue to press in an inward direction relative to thehousing member.
 403. The system of claim 399, wherein the tissuestabilizing device applies a stimulation to a target tissue.
 404. Atissue penetrating system, comprising: a housing member; a plurality ofpenetrating members; and a stimulating member coupled to the housingmember and configured to increase blood circulation at a skin surface.405. A skin penetrating system, comprising: a housing member; aplurality of penetrating members positioned in the housing member, atissue stabilizing device coupled to the housing member; and a userinterface configured to relay at least one of, skin penetratingperformance or a skin penetrating setting.
 406. The system of claim 405,wherein the user interface is configured to provide a user with at leastone input selected from, depth of a penetrating member penetration,velocity of a penetrating member, a desired velocity profile, a velocityof a penetrating member into the target tissue, velocity of thepenetrating member out of the target tissue, dwell time of thepenetrating member in the target tissue, and a target tissue relaxationparameter.
 407. The system of claim 405, wherein the user interfaceprovides at least one output to the user selected from, number ofpenetrating members available, number of penetrating members used,actual depth of penetrating member penetration on a target tissue,stratum corneum thickness, force delivered on a target tissue, energyused by a penetrating member driver to drive a penetrating member intothe target tissue, dwell time of the penetrating member, battery status,system status, consumed energy, speed profile of a penetrating member,information relative to contact of a penetrating member with targettissue before penetration by the penetrating member, and informationrelative to a change of speed of a penetrating member as in travels inthe target tissue.
 408. The system of claim 405, further comprising: adata interface configured to couple the tissue penetrating system to atleast one of, support equipment with a data interface and the internet.409. The system of claim 405, wherein the support equipment is selectedfrom at least one of, a base station, home computer, central server, andmain processing equipment for storing glucose level information. 410.The system of claim 405, wherein each penetrating member is a barepenetrating member without a penetrating member body or modeledattachment during launch of the penetrating member.
 411. The system ofclaim 405, wherein the tissue stabilizer member is configured to enhancefluid flow from a target tissue.
 412. The system of claim 405, whereinthe tissue stabilizer member creates a stretching of a skin surface.413. The system of claim 405, wherein the tissue stabilizer member isconfigured to apply a force to a target tissue and cause the targettissue to press in an inward direction relative to the housing member.414. The system of claim 405, wherein the tissue stabilizing deviceapplies a stimulation to a target tissue.
 415. A body fluid samplingsystem for use on a tissue site, the system comprising: a drive forcegenerator; a penetrating member operatively coupled to said forcegenerator, said force generator moving said member along a path out of ahousing having a penetrating member exit, into said tissue site,stopping in said tissue site, and withdrawing out of said tissue site;wherein said penetrating member is an elongate member without a moldedattachment; a coupler on said force generator configured to engage atleast a portion of said elongate portion of the penetrating member anddrive said member along a path into a tissue site and withdrawn from atissue site; a cartridge housing said penetrating member, said cartridgehaving a first and a second seal coupled to said penetrating member tomaintain a sterile environment around a portion of the penetrationmember prior to penetrating member actuation; and a user interfaceconfigured to relay at least one of penetrating member performance or apenetrating member setting.
 416. A body fluid sampling system for use ona tissue site, the system comprising: a drive force generator; apenetrating member operatively coupled to said force generator, saidforce generator moving said member along a path out of a housing havinga penetrating member exit, into said tissue site, stopping in saidtissue site, and withdrawing out of said tissue site; wherein saidpenetrating member is an elongate member without a molded attachment; acoupler on said force generator configured to engage at least a portionof said elongate portion of the penetrating member and drive said memberalong a path into a tissue site and withdrawn from a tissue site; acartridge housing said penetrating member, said cartridge having a firstand a second seal coupled to said penetrating member to maintain asterile environment around a portion of the penetration member prior topenetrating member actuation; and a human interface providing at leastone output.
 417. A body fluid sampling system for use on a tissue site,the system comprising: a drive force generator; a plurality ofcartridges each containing a penetrating member, each of said cartridgescoupled together to define a flexible array; a transport device formoving each of said cartridges into a launch position operativelycoupling said penetrating member to the force generator; each cartridgehaving a first and a second seal coupled to said penetrating member tomaintain a sterile environment around a portion of the penetrationmember prior to penetrating member actuation; and a user interfaceconfigured to relay at least one of, penetrating member performance or apenetrating member setting.
 418. A body fluid sampling system for use ona tissue site, the system comprising: a drive force generator; aplurality of cartridges each containing a penetrating member, each ofsaid cartridges coupled together to define a flexible array; a transportdevice for moving each of said cartridges into a launch positionoperatively coupling said penetrating member to the force generator;each cartridge having a first and a second seal coupled to saidpenetrating member to maintain a sterile environment around a portion ofthe penetration member prior to penetrating member actuation; and ahuman interface providing at least one output.
 419. A body fluidsampling system for use on a tissue site, the system comprising: a driveforce generator; a penetrating member having an elongate portion withouta molded attachment and operatively coupled to said force generator; asterility enclosure covering at least a tip of said penetrating member,said sterility enclosure removed from said penetrating member prior toactuation of the member and positioned so that the penetrating memberwill not contact said enclosure during actuation; and a user interfaceconfigured to relay at least one of, penetrating member performance or apenetrating member setting.
 420. A body fluid sampling system for use ona tissue site, the system comprising: a drive force generator; apenetrating member having an elongate portion without a moldedattachment and operatively coupled to said force generator; a sterilityenclosure covering at least a tip of said penetrating member, saidsterility enclosure removed from said penetrating member prior toactuation of the member and positioned so that the penetrating memberwill not contact said enclosure during actuation; and a human interfaceproviding at least one output.
 421. A body fluid sampling system for useon a tissue site, the system comprising: a drive force generator; apenetrating member having an elongate portion without a moldedattachment and operatively coupled to said force generator; a sterilityenclosure creating a sterile environment around at least a tip of saidpenetrating member, said penetrating member breaching said sterileenvironment during actuation; and a user interface configured to relayat least one of, penetrating member performance or a penetrating membersetting.
 422. A body fluid sampling system for use on a tissue site, thesystem comprising: a drive force generator; a penetrating member havingan elongate portion without a molded attachment and operatively coupledto said force generator; a sterility enclosure creating a sterileenvironment around at least a tip of said penetrating member, saidpenetrating member breaching said sterile environment during actuation;and a human interface providing at least one output.
 423. A body fluidsampling system for use on a tissue site, the system comprising: a driveforce generator; a penetrating member operatively coupled to said forcegenerator, said force generator moving said member along a path out of ahousing having said a penetrating member exit, into said tissue site,stopping in said tissue site, and withdrawing out of said tissue site; askin stabilizer device suitable for stretching a surface of a tissuesite, said skin stabilizer at least partially surrounding thepenetrating member exit; a cartridge housing said penetrating member,said cartridge having a first and a second seal coupled to saidpenetrating member to maintain a sterile environment around a portion ofthe penetration member prior to penetrating member actuation; and a userinterface configured to relay at least one of, penetrating memberperformance or a penetrating member setting.
 424. A body fluid samplingsystem for use on a tissue site, the system comprising: a drive forcegenerator; a penetrating member operatively coupled to said forcegenerator, said force generator moving said member along a path out of ahousing having said a penetrating member exit, into said tissue site,stopping in said tissue site, and withdrawing out of said tissue site; askin stabilizer device suitable for stretching a surface of a tissuesite, said skin stabilizer at least partially surrounding thepenetrating member exit; a cartridge housing said penetrating member,said cartridge having a first and a second seal coupled to saidpenetrating member to maintain a sterile environment around a portion ofthe penetration member prior to penetrating member actuation; and ahuman interface providing at least one output.
 425. A body fluidsampling system for use on a tissue site, the system comprising: a driveforce generator; a penetrating member operatively coupled to said forcegenerator, said force generator moving said member along a path out of ahousing having said a penetrating member exit, into said tissue site,stopping in said tissue site, and withdrawing out of said tissue site; acartridge housing said penetrating member, said cartridge having a firstand a second seal coupled to said penetrating member to maintain asterile environment around a portion of the penetration member prior topenetrating member actuation; and a user interface configured to relayat least one of, penetrating member performance or a penetrating membersetting.
 426. A body fluid sampling system for use on a tissue site, thesystem comprising: a drive force generator; a penetrating memberoperatively coupled to said force generator, said force generator movingsaid member along a path out of a housing having said a penetratingmember exit, into said tissue site, stopping in said tissue site, andwithdrawing out of said tissue site; a cartridge housing saidpenetrating member, said cartridge having a first and a second sealcoupled to said penetrating member to maintain a sterile environmentaround a portion of the penetration member prior to penetrating memberactuation; and a human interface providing at least one output.
 427. Abody fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a penetrating member operativelycoupled to said force generator, said force generator moving said memberalong a path out of a housing having a penetrating member exit, intosaid tissue site, stopping in said tissue site, and withdrawing out ofsaid tissue site; an analyte detection member positioned to receivefluid from a wound created by said penetrating member, said detectionmember configured to determine a concentration of an analyte in thefluid using a sample of less than 1 mL of the fluid; a cartridge housingsaid penetrating member, said cartridge having a first and a second sealcoupled to said penetrating member to maintain a sterile environmentaround a portion of the penetration member prior to penetrating memberactuation; and a user interface configured to relay at least one of,penetrating member performance or a penetrating member setting.
 428. Abody fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a penetrating member operativelycoupled to said force generator, said force generator moving said memberalong a path out of a housing having a penetrating member exit, intosaid tissue site, stopping in said tissue site, and withdrawing out ofsaid tissue site; an analyte detection member positioned to receivefluid from a wound created by said penetrating member, said detectionmember configured to determine a concentration of an analyte in thefluid using a sample of less than 1 mL of the fluid; a cartridge housingsaid penetrating member, said cartridge having a first and a second sealcoupled to said penetrating member to maintain a sterile environmentaround a portion of the penetration member prior to penetrating memberactuation; and a human interface providing at least one output.
 429. Abody fluid sampling system for use on a tissue site, the systemcomprising: a single drive force generator; a plurality of penetratingmembers operatively coupled to said force generator, said forcegenerator moving each of said members along a path out of a housinghaving a penetrating member exit, into said tissue site, stopping insaid tissue site, and withdrawing out of said tissue site; a flexiblesupport member coupling said penetrating members to define a lineararray, said support member being movable and configured to move each ofsaid penetrating members to a launch position associated with said forcegenerator; and a user interface configured to relay at least one of,penetrating member performance or a penetrating member setting.
 430. Thesystem of claim 429, wherein the user interface is configured to providea user with at least one input selected from, depth of a penetratingmember penetration, velocity of a penetrating member, a desired velocityprofile, a velocity of a penetrating member into the target tissue,velocity of the penetrating member out of the target tissue, dwell timeof the penetrating member in the target tissue, and a target tissuerelaxation parameter.
 431. The system of claim 429, further comprising:a data interface configured to couple the tissue penetrating system toat least one of, support equipment with a data interface and theinternet.
 432. A body fluid sampling system for use on a tissue site,the system comprising: a single drive force generator; a plurality ofpenetrating members operatively coupled to said force generator, saidforce generator moving each of said members along a path out of ahousing having a penetrating member exit, into said tissue site,stopping in said tissue site, and withdrawing out of said tissue site; aflexible support member coupling said penetrating members to define alinear array, said support member being movable and configured to moveeach of said penetrating members to a launch position associated withsaid force generator; and a human interface providing at least oneoutput.
 433. The system of claim 432, wherein the at least one output isselected from, a penetration event of a penetrating member, number ofpenetrating members remaining, time of day, alarm, penetrating membertrajectory waveform profile information, force for last penetrationevent, the last penetration event, how or low battery status, analytestatus, time to change cassette status, jamming malfunction, and systemstatus.
 434. The system of claim 432, wherein the housing is selectedfrom at least one of, a telephone, a watch, a PDA, electronic device,medical device, point of care device and a decentralized diagnosticdevice.
 435. The system of claim 432, further comprising: an inputdevice coupled to the housing, the input device selected from one ormore pushbuttons, a touch pad independent of the display device, or atouch sensitive screen on a visual display.
 436. The system of claim432, further comprising: a data exchange device for coupling the tissuepenetrating system to support equipment.
 437. The system of claim 436,further comprising: a data interface configured to couple the tissuepenetrating system to support equipment with a data interface.
 438. Abody fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a plurality of penetrating membersoperatively coupled to said force generator, said force generator movingeach of said members along a path out of a housing having a penetratingmember exit, into said tissue site, stopping in said tissue site, andwithdrawing out of said tissue site; a flexible support member couplingsaid penetrating members to define a linear array, said support memberbeing movable and configured to move each of said penetrating members toa launch position associated with said force generator; wherein saidpenetrating member is an elongate member without a molded attachment; acoupler on said force generator configured to engage at least a portionof said elongate portion of the penetrating member and drive said memberalong a path into a tissue site and withdrawn from a tissue site; and auser interface configured to relay at least one of, penetrating memberperformance or a penetrating member setting.
 439. A body fluid samplingsystem for use on a tissue site, the system comprising: a drive forcegenerator; a plurality of penetrating members operatively coupled tosaid force generator, said force generator moving each of said membersalong a path out of a housing having a penetrating member exit, intosaid tissue site, stopping in said tissue site, and withdrawing out ofsaid tissue site; a flexible support member coupling said penetratingmembers to define a linear array, said support member being movable andconfigured to move each of said penetrating members to a launch positionassociated with said force generator; wherein said penetrating member isan elongate member without a molded attachment; a coupler on said forcegenerator configured to engage at least a portion of said elongateportion of the penetrating member and drive said member along a pathinto a tissue site and withdrawn from a tissue site; and a humaninterface providing at least one output.
 440. A body fluid samplingsystem for use on a tissue site, the system comprising: a drive forcegenerator; a plurality of penetrating members operatively coupled tosaid force generator, said force generator moving each of said membersalong a path out of a housing having a penetrating member exit, intosaid tissue site, stopping in said tissue site, and withdrawing out ofsaid tissue site; a flexible support member coupling said penetratingmembers to define a linear array, said support member being movable andconfigured to move each of said penetrating members to a launch positionassociated with said force generator; a sterility enclosure covering atleast a tip of said penetrating member, said sterility enclosure removedfrom said penetrating member prior to actuation of the member andpositioned so that the penetrating member will not contact saidenclosure during actuation; and a user interface configured to relay atleast one of, penetrating member performance or a penetrating membersetting.
 441. A body fluid sampling system for use on a tissue site, thesystem comprising: a drive force generator; a plurality of penetratingmembers operatively coupled to said force generator, said forcegenerator moving each of said members along a path out of a housinghaving a penetrating member exit, into said tissue site, stopping insaid tissue site, and withdrawing out of said tissue site; a flexiblesupport member coupling said penetrating members to define a lineararray, said support member being movable and configured to move each ofsaid penetrating members to a launch position associated with said forcegenerator; a sterility enclosure covering at least a tip of saidpenetrating member, said sterility enclosure removed from saidpenetrating member prior to actuation of the member and positioned sothat the penetrating member will not contact said enclosure duringactuation; and a human interface providing at least one output.
 442. Abody fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a plurality of penetrating membersoperatively coupled to said force generator, said force generator movingeach of said members along a path out of a housing having a penetratingmember exit, into said tissue site, stopping in said tissue site, andwithdrawing out of said tissue site; a flexible support member couplingsaid penetrating members to define a linear array, said support memberbeing movable and configured to move each of said penetrating members toa launch position associated with said force generator; a sterilityenclosure creating a sterile environment around at least a tip of saidpenetrating member, said penetrating member breaching said sterileenvironment during actuation; and a user interface configured to relayat least one of, penetrating member performance or a penetrating membersetting.
 443. A body fluid sampling system for use on a tissue site, thesystem comprising: a drive force generator; a plurality of penetratingmembers operatively coupled to said force generator, said forcegenerator moving each of said members along a path out of a housinghaving a penetrating member exit, into said tissue site, stopping insaid tissue site, and withdrawing out of said tissue site; a flexiblesupport member coupling said penetrating members to define a lineararray, said support member being movable and configured to move each ofsaid penetrating members to a launch position associated with said forcegenerator; a sterility enclosure creating a sterile environment aroundat least a tip of said penetrating member, said penetrating memberbreaching said sterile environment during actuation; and a humaninterface providing at least one output.
 444. A body fluid samplingsystem for use on a tissue site, the system comprising: a drive forcegenerator; a plurality of penetrating members operatively coupled tosaid force generator, said force generator moving each of said membersalong a path out of a housing having a penetrating member exit, intosaid tissue site, stopping in said tissue site, and withdrawing out ofsaid tissue site; a flexible support member coupling said penetratingmembers to define a linear array, said support member being movable andconfigured to move each of said penetrating members to a launch positionassociated with said force generator; a skin stabilizer device suitablefor stretching a surface of a tissue site, said skin stabilizer at leastpartially surrounding the penetrating member exit; and a user interfaceconfigured to relay at least one of, penetrating member performance or apenetrating member setting.
 445. A body fluid sampling system for use ona tissue site, the system comprising: a drive force generator; aplurality of penetrating members operatively coupled to said forcegenerator, said force generator moving each of said members along a pathout of a housing having a penetrating member exit, into said tissuesite, stopping in said tissue site, and withdrawing out of said tissuesite; a flexible support member coupling said penetrating members todefine a linear array, said support member being movable and configuredto move each of said penetrating members to a launch position associatedwith said force generator; a skin stabilizer device suitable forstretching a surface of a tissue site, said skin stabilizer at leastpartially surrounding the penetrating member exit; and a human interfaceproviding at least one output.
 446. A body fluid sampling system for useon a tissue site, the system comprising: a drive force generator; aplurality of penetrating members operatively coupled to said forcegenerator, said force generator moving each of said members along a pathout of a housing having a penetrating member exit, into said tissuesite, stopping in said tissue site, and withdrawing out of said tissuesite; a flexible support member coupling said penetrating members todefine a linear array, said support member being movable and configuredto move each of said penetrating members to a launch position associatedwith said force generator; and a user interface for transmitting atleast one input between a user.
 447. A body fluid sampling system foruse on a tissue site, the system comprising: a drive force generator; aplurality of penetrating members operatively coupled to said forcegenerator, said force generator moving each of said members along a pathout of a housing having a penetrating member exit, into said tissuesite, stopping in said tissue site, and withdrawing out of said tissuesite; a flexible support member coupling said penetrating members todefine a linear array, said support member being movable and configuredto move each of said penetrating members to a launch position associatedwith said force generator; and a user interface configured to relay atleast one of, penetrating member performance or a penetrating membersetting.
 448. A body fluid sampling system for use on a tissue site, thesystem comprising: a drive force generator; a plurality of penetratingmembers operatively coupled to said force generator, said forcegenerator moving each of said members along a path out of a housinghaving a penetrating member exit, into said tissue site, stopping insaid tissue site, and withdrawing out of said tissue site; a flexiblesupport member coupling said penetrating members to define a lineararray, said support member being movable and configured to move each ofsaid penetrating members to a launch position associated with said forcegenerator; and a human interface providing at least one output.
 449. Abody fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a plurality of penetrating membersoperatively coupled to said force generator, said force generator movingeach of said members along a path out of a housing having a penetratingmember exit, into said tissue site, stopping in said tissue site, andwithdrawing out of said tissue site; a flexible support member couplingsaid penetrating members to define a linear array, said support memberbeing movable and configured to move each of said penetrating members toa launch position associated with said force generator; an analytedetection member positioned to receive fluid from a wound created bysaid penetrating member, said detection member configured to determine aconcentration of an analyte in the fluid using a sample of less than 1mL of the fluid; and a user interface configured to relay at least oneof, penetrating member performance or a penetrating member setting. 450.A body fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a plurality of penetrating membersoperatively coupled to said force generator, said force generator movingeach of said members along a path out of a housing having a penetratingmember exit, into said tissue site, stopping in said tissue site, andwithdrawing out of said tissue site; a flexible support member couplingsaid penetrating members to define a linear array, said support memberbeing movable and configured to move each of said penetrating members toa launch position associated with said force generator; an analytedetection member positioned to receive fluid from a wound created bysaid penetrating member, said detection member configured to determine aconcentration of an analyte in the fluid using a sample of less than 1mL of the fluid; and a human interface providing at least one output.451. A tissue penetrating system, comprising: a plurality of penetratingmembers; a penetrating member driver coupled to the plurality ofpenetrating members; a cartridge transport device; and a plurality ofcartridges each associated with a penetrating member, the cartridgetransport device being configured to move each cartridge to a positionaligning a penetrating member with the penetrating member driver todrive the penetrating member along a path into a target tissue site.452. The system of claim 451, further comprising: a plurality ofcartridges integrated in a cassette.
 453. The system of claim 452,wherein each cartridge has an exit port, and upon launch eachpenetrating member exists from the exit port.
 454. The system of claim451, further comprising: an analyte detecting member.
 455. The system ofclaim 451, further comprising: a plurality of analyte detecting memberseach coupled to a penetrating member.
 456. The system of claim 451,further comprising: a sample chamber with an opening for transport of abody fluid into the sample chamber, the sample chamber being sized toreceive no more than 1.0 μL of the body fluid.
 457. The system of claim451, further comprising: a tissue stabilizer device coupled to thehousing.
 458. The system of claim 457, wherein the tissue stabilizerdevice is configured to enhance fluid flow from a target tissue. 459.The system of claim 457, wherein the tissue stabilizer device creates astretching of a skin surface.
 460. The system of claim 457, wherein thetissue stabilizer device is configured to apply a force to a targettissue and cause the target tissue to press in an inward directionrelative to the housing member.
 461. The system of claim 457, whereinthe tissue stabilizing member applies a stimulation to a target tissue.462. The system of claim 451, further comprising: a seal formed by afracturable material between the penetrating member and a cartridge, theseal being positioned at least one of a distal port or a proximal portof the cartridge.
 463. The system of claim 457, further comprising: asecond fracturable seal located at least one of the distal port orproximal port of a cartridge.
 464. The system of claim 451, wherein eachpenetrating member each penetrating members is an elongate memberwithout molded attachments.
 465. The system of claim 451, furthercomprising: a belt for holding the penetrating members in an arrayconfiguration.
 466. The system of claim 451, further comprising: a tapedevice configured to hold the penetrating members in an arrayconfiguration.
 467. The system of claim 451, further comprising: asupport channel configured to hold the penetrating members in an arrayconfiguration.
 468. The system of claim 451, further comprising: a cogconfigured to hold the penetrating members in an array configuration.469. The system of claim 451, further comprising: a plurality ofconnectors between penetrating members for holding the penetratingmembers in an array configuration.
 470. The system of claim 451, furthercomprising: a support structure for receiving the penetrating members.471. The system of claim 470, wherein the support structure is abandolier
 472. The system of claim 471, wherein the support structure isa drum.
 473. A tissue penetrating system, comprising: a plurality ofpenetrating members each with a tip; a penetrating member driver coupledto the plurality of penetrating members; a support with a plurality ofopenings, each opening receiving a penetrating member, each tip of apenetrating member being uncovered during launch of a penetrating memberby the penetrating driver member; and a user interface configured torelay at least one of, skin penetrating performance or a skinpenetrating setting.
 474. The system of claim 473, wherein the userinterface is configured to provide a user with at least one inputselected from, depth of a penetrating member penetration, velocity of apenetrating member, a desired velocity profile, a velocity of apenetrating member into the target tissue, velocity of the penetratingmember out of the target tissue, dwell time of the penetrating member inthe target tissue, and a target tissue relaxation parameter.
 475. Thesystem of claim 473, further comprising: a data interface configured tocouple the tissue penetrating system to at least one of, supportequipment with a data interface and the internet.
 476. The system ofclaim 473, wherein the support equipment is selected from at least oneof, a base station, home computer, central server, and main processingequipment for storing glucose level information.
 477. A tissuepenetrating system, comprising: a plurality of penetrating members eachwith a tip; a penetrating member driver coupled to the plurality ofpenetrating members; a support with a plurality of openings, eachopening receiving a penetrating member, each tip of a penetrating memberbeing uncovered during launch of a penetrating member by the penetratingdriver member; and a human interface providing at least one output. 478.The system of claim 477, wherein the at least one output is selectedfrom, a penetration event of a penetrating member, number of penetratingmembers remaining, time of day, alarm, penetrating member trajectorywaveform profile information, force for last penetration event, the lastpenetration event, how or low battery status, analyte status, time tochange cassette status, jamming malfunction, and system status.
 479. Thesystem of claim 477, wherein the housing is selected from at least oneof, a telephone, a watch, a PDA, electronic device, medical device,point of care device and a decentralized diagnostic device.
 480. Thesystem of claim 477, further comprising: an input device coupled to thehousing, the input device selected from one or more pushbuttons, a touchpad independent of the display device, or a touch sensitive screen on avisual display.
 481. The system of claim 477, further comprising: a dataexchange device for coupling the tissue penetrating system to supportequipment.
 482. The system of claim 481, further comprising: a datainterface configured to couple the tissue penetrating system to supportequipment with a data interface.
 483. A tissue penetration device,comprising: a penetrating member driver; a cartridge; a plurality ofpenetrating members integrated with the cartridge, each of a penetratingmember coupled to the penetrating member driver when advanced along apath into a tissue target; and a user interface configured to relay atleast one of, skin penetrating performance or a skin penetratingsetting.
 484. The system of claim 483, wherein the user interface isconfigured to provide a user with at least one input selected from,depth of a penetrating member penetration, velocity of a penetratingmember, a desired velocity profile, a velocity of a penetrating memberinto the target tissue, velocity of the penetrating member out of thetarget tissue, dwell time of the penetrating member in the targettissue, and a target tissue relaxation parameter.
 485. The system ofclaim 483, wherein the support equipment is selected from at least oneof, a base station, home computer, central server, and main processingequipment for storing glucose level information.
 486. A body fluidsampling system for use on a tissue site, the system comprising: a driveforce generator; a penetrating member operatively coupled to said forcegenerator, said force generator moving said member along a path out of ahousing having a penetrating member exit, into said tissue site,stopping in said tissue site, and withdrawing out of said tissue site;wherein said penetrating member is an elongate member without a moldedattachment; a coupler on said force generator configured to engage atleast a portion of said elongate portion of the penetrating member anddrive said member along a path into a tissue site and withdrawn from atissue site; and a cartridge housing said penetrating member, saidcartridge having a first and a second seal coupled to said penetratingmember to maintain a sterile environment around a portion of thepenetration member prior to penetrating member actuation.
 487. A bodyfluid sampling system for use on a tissue site, the system comprising: adrive force generator; a plurality of cartridges each containing apenetrating member, each of said cartridges coupled together to define aflexible array; a transport device for moving each of said cartridgesinto a launch position operatively coupling said penetrating member tothe force generator; each cartridge having a first and a second sealcoupled to said penetrating member to maintain a sterile environmentaround a portion of the penetration member prior to penetrating memberactuation.
 488. A body fluid sampling system for use on a tissue site,the system comprising: a drive force generator; a penetrating memberhaving an elongate portion without a molded attachment and operativelycoupled to said force generator; and a sterility enclosure covering atleast a tip of said penetrating member, said sterility enclosure removedfrom said penetrating member prior to actuation of the member andpositioned so that the penetrating member will not contact saidenclosure during actuation.
 489. A body fluid sampling system for use ona tissue site, the system comprising: a drive force generator; apenetrating member having an elongate portion without a moldedattachment and operatively coupled to said force generator; and asterility enclosure creating a sterile environment around at least a tipof said penetrating member, said penetrating member breaching saidsterile environment during actuation.
 490. A body fluid sampling systemfor use on a tissue site, the system comprising: a drive forcegenerator; a penetrating member operatively coupled to said forcegenerator, said force generator moving said member along a path out of ahousing having said a penetrating member exit, into said tissue site,stopping in said tissue site, and withdrawing out of said tissue site; askin stabilizer device suitable for stretching a surface of a tissuesite, said skin stabilizer at least partially surrounding thepenetrating member exit; and a cartridge housing said penetratingmember, said cartridge having a first and a second seal coupled to saidpenetrating member to maintain a sterile environment around a portion ofthe penetration member prior to penetrating member actuation.
 491. Abody fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a penetrating member operativelycoupled to said force generator, said force generator moving said memberalong a path out of a housing having said a penetrating member exit,into said tissue site, stopping in said tissue site, and withdrawing outof said tissue site; a user interface for transmitting at least oneinput between a user; and a cartridge housing said penetrating member,said cartridge having a first and a second seal coupled to saidpenetrating member to maintain a sterile environment around a portion ofthe penetration member prior to penetrating member actuation.
 492. Abody fluid sampling system for use on a tissue site, the systemcomprising: a drive force generator; a penetrating member operativelycoupled to said force generator, said force generator moving said memberalong a path out of a housing having a penetrating member exit, intosaid tissue site, stopping in said tissue site, and withdrawing out ofsaid tissue site; an analyte detection member positioned to receivefluid from a wound created by said penetrating member, said detectionmember configured to determine a concentration of an analyte in thefluid using a sample of less than 1 mL of the fluid; and a cartridgehousing said penetrating member, said cartridge having a first and asecond seal coupled to said penetrating member to maintain a sterileenvironment around a portion of the penetration member prior topenetrating member actuation.
 493. A tissue penetrating system,comprising: a plurality of cartridges each with a distal port and aproximal port; a plurality of penetrating members each coupled to acartridge, each penetrating member having a sharpened distal tip and ashaft portion slidably disposed within the cartridge; a seal formed by afracturable material between the penetrating member and the cartridge,the seal being positioned at least one of a distal port or a proximalport of the cartridge; and a user interface configured to relay at leastone of, skin penetrating performance or a skin penetrating setting. 494.The system of claim 493, wherein the user interface is configured toprovide a user with at least one input selected from, depth of apenetrating member penetration, velocity of a penetrating member, adesired velocity profile, a velocity of a penetrating member into thetarget tissue, velocity of the penetrating member out of the targettissue, dwell time of the penetrating member in the target tissue, and atarget tissue relaxation parameter.
 495. The system of claim 493,further comprising: a data interface configured to couple the tissuepenetrating system to at least one of, support equipment with a datainterface and the internet.
 496. The system of claim 495, wherein thesupport equipment is selected from at least one of, a base station, homecomputer, central server, and main processing equipment for storingglucose level information.
 497. A tissue penetrating system, comprising:a plurality of cartridges each with a distal port and a proximal port; aplurality of penetrating members each coupled to a cartridge, eachpenetrating member having a sharpened distal tip and a shaft portionslidably disposed within the cartridge; a seal formed by a fracturablematerial between the penetrating member and the cartridge, the sealbeing positioned at least one of a distal port or a proximal port of thecartridge; and a human interface coupled providing at least one output.498. The system of claim 497, wherein the at least one output isselected from, a penetration event of a penetrating member, number ofpenetrating members remaining, time of day, alarm, penetrating membertrajectory waveform profile information, force for last penetrationevent, the last penetration event, how or low battery status, analytestatus, time to change cassette status, jamming malfunction, and systemstatus.
 499. The system of claim 497, wherein the housing is selectedfrom at least one of, a telephone, a watch, a PDA, electronic device,medical device, point of care device and a decentralized diagnosticdevice.
 500. The system of claim 497, further comprising: an inputdevice coupled to the housing, the input device selected from one ormore pushbuttons, a touch pad independent of the display device, or atouch sensitive screen on a visual display.
 501. The system of claim497, further comprising: a data exchange device for coupling the tissuepenetrating system to support equipment.
 502. The system of claim 501,further comprising: a data interface configured to couple the tissuepenetrating system to support equipment with a data interface.
 503. Atissue penetrating system, comprising: a cartridge with a distal portand a proximal port; a plurality of penetrating members each with asharpened distal tip and a shaft portion slidably disposed within thecartridge; a seal formed by a fracturable material between thepenetrating member and the cartridge, the seal being positioned at leastone of a distal port or a proximal port of the cartridge; and a userinterface configured to relay at least one of, skin penetratingperformance or a skin penetrating setting.
 504. The system of claim 503,wherein the user interface is configured to provide a user with at leastone input selected from, depth of a penetrating member penetration,velocity of a penetrating member, a desired velocity profile, a velocityof a penetrating member into the target tissue, velocity of thepenetrating member out of the target tissue, dwell time of thepenetrating member in the target tissue, and a target tissue relaxationparameter.
 505. The system of claim 503, further comprising: a datainterface configured to couple the tissue penetrating system to at leastone of, support equipment with a data interface and the internet. 506.The system of claim 505, wherein the support equipment is selected fromat least one of, a base station, home computer, central server, and mainprocessing equipment for storing glucose level information.
 507. Atissue penetrating system, comprising: a cartridge with a distal portand a proximal port; a plurality of penetrating members each with asharpened distal tip and a shaft portion slidably disposed within thecartridge; a seal formed by a fracturable material between thepenetrating member and the cartridge, the seal being positioned at leastone of a distal port or a proximal port of the cartridge; and a humaninterface providing at least one output.
 508. The system of claim 507,wherein the at least one output is selected from, a penetration event ofa penetrating member, number of penetrating members remaining, time ofday, alarm, penetrating member trajectory waveform profile information,force for last penetration event, the last penetration event, how or lowbattery status, analyte status, time to change cassette status, jammingmalfunction, and system status.
 509. The system of claim 507, whereinthe housing is selected from at least one of, a telephone, a watch, aPDA, electronic device, medical device, point of care device and adecentralized diagnostic device.
 510. The system of claim 507, furthercomprising: an input device coupled to the housing, the input deviceselected from one or more pushbuttons, a touch pad independent of thedisplay device, or a touch sensitive screen on a visual display. 511.The system of claim 507, further comprising: a data exchange device forcoupling the tissue penetrating system to support equipment.
 512. Thesystem of claim 511, further comprising: a data interface configured tocouple the tissue penetrating system to support equipment with a datainterface.
 513. A tissue penetrating system, comprising: a cartridgewith a distal port and a proximal port; a plurality of sample chambers;a plurality of penetrating members each with a sharpened distal tip anda shaft portion slidably disposed within the cartridge, each penetratingmember being associated with a sample chamber; a first seal formed atthe distal port and a second seal formed at the proximal port, whereinprior to lancing the first seal and second seal maintain the distal tipof a penetrating member and the sample chamber in a sterile environment;and a user interface configured to relay at least one of, skinpenetrating performance or a skin penetrating setting.
 514. The systemof claim 513, wherein the at least one output is selected from, apenetration event of a penetrating member, number of penetrating membersremaining, time of day, alarm, penetrating member trajectory waveformprofile information, force for last penetration event, the lastpenetration event, how or low battery status, analyte status, time tochange cassette status, jamming malfunction, and system status.
 515. Thesystem of claim 513, wherein the housing is selected from at least oneof, a telephone, a watch, a PDA, electronic device, medical device,point of care device and a decentralized diagnostic device.
 516. Thesystem of claim 513, further comprising: an input device coupled to thehousing, the input device selected from one or more pushbuttons, a touchpad independent of the display device, or a touch sensitive screen on avisual display.
 517. The system of claim 513, further comprising: a dataexchange device for coupling the tissue penetrating system to supportequipment.
 518. The system of claim 517, further comprising: a datainterface configured to couple the tissue penetrating system to supportequipment with a data interface.
 519. A tissue penetrating system,comprising: a cartridge with a distal port and a proximal port; aplurality of sample chambers; a plurality of penetrating members eachwith a sharpened distal tip and a shaft portion slidably disposed withinthe cartridge, each penetrating member being associated with a samplechamber; a first seal formed at the distal port and a second seal formedat the proximal port, wherein prior to lancing the first seal and secondseal maintain the distal tip of a penetrating member and the samplechamber in a sterile environment; and a human interface providing atleast one output.
 520. The system of claim 519, wherein the at least oneoutput is selected from, a penetration event of a penetrating member,number of penetrating members remaining, time of day, alarm, penetratingmember trajectory waveform profile information, force for lastpenetration event, the last penetration event, how or low batterystatus, analyte status, time to change cassette status, jammingmalfunction, and system status.
 521. The system of claim 519, whereinthe housing is selected from at least one of, a telephone, a watch, aPDA, electronic device, medical device, point of care device and adecentralized diagnostic device.
 522. The system of claim 519, furthercomprising: an input device coupled to the housing, the input deviceselected from one or more pushbuttons, a touch pad independent of thedisplay device, or a touch sensitive screen on a visual display. 523.The system of claim 519, further comprising: a data exchange device forcoupling the tissue penetrating system to support equipment.
 524. Thesystem of claim 523, further comprising: a data interface configured tocouple the tissue penetrating system to support equipment with a datainterface.
 525. A body fluid sampling system for use on a tissue site,the system comprising: a drive force generator; a penetrating memberhaving an elongate portion without a molded attachment and operativelycoupled to said force generator; a sterility enclosure creating asterile environment around at least a tip of said penetrating member,said penetrating member breaching said sterile environment duringactuation; and a tissue stabilizing member associated with said housingand positioned to at least partially surround an impact location of thepenetrating member on the tissue site.
 526. A body fluid sampling systemfor use on a tissue site, the system comprising: a drive forcegenerator; a penetrating member operatively coupled to said forcegenerator, said force generator moving said member along a path out of ahousing having a penetrating member exit, into said tissue site,stopping in said tissue site, and withdrawing out of said tissue site;an analyte detection member positioned to receive fluid from a woundcreated by said penetrating member, said detection member configured todetermine a concentration of an analyte in the fluid using a sample ofless than 1 μL of the fluid; and a tissue stabilizing member associatedwith said housing and positioned to at least partially surround animpact location of the penetrating member on the tissue site.